FDA Accepts Amgen's Filing Of A Supplemental New Drug Application To Add Overall Survival Results To KYPROLIS® (Carfilzomib) Label
FDA Sets PDUFA Target Action Date of April 30, 2018 THOUSAND OAKS, Calif. , Aug. 30, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has accepted for review a supplemental New Drug Application (sNDA) based on the overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial demonstrating that KYPROLIS® (carfilzomib) and dexamethasone (Kd) reduced the risk of death by 21 percent and increased OS by 7.6 months versus Velcade® (bortezomib) and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma (median OS 47.6 months for Kd versus 40.0 months for Vd, HR=0.79; p=0.01). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of April 30, 2018 . "Effective proteasome inhibition is an essential approach to treating multiple myeloma. Patients in the ENDEAVOR study receiving KYPROLIS and dexamethasone lived 7.6 months longer than those on Velcade and dexamethasone," said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen . "These data, along with compelling overall survival results from the Phase 3 ASPIRE trial, clearly demonstrate that KYPROLIS-based regimens should be considered new standards of care for appropriate patients with relapsed multiple myeloma." If approved by the FDA , the KYPROLIS U.S. prescribing information will include this data from the ENDEAVOR trial showing that KYPROLIS, administered at the 56 mg/m2 dose as a 30-minute infusion twice weekly with dexamethasone, helped relapsed or refractory multiple myeloma patients live longer than patients administered Vd. Full results from the ENDEAVOR OS analysis were recently published online in The Lancet Oncology. Adverse events observed in this updated analysis were consistent with those previously reported for ENDEAVOR. The most common adverse events (greater than or equal to 20 percent) in the KYPROLIS arm were anemia, diarrhea, pyrexia, dyspnea, fatigue, hypertension, cough, insomnia, upper respiratory tract infection, peripheral edema, nausea, bronchitis, asthenia, back pain, thrombocytopenia and headache. Since its approval in 2012, more than 50,000 patients worldwide have received KYPROLIS. The KYPROLIS clinical program continues to focus on providing solutions for physicians and patients in treating this frequently relapsing and difficult-to-treat cancer. KYPROLIS is available for patients whose myeloma has relapsed or become resistant to another treatment and continues to be studied in a range of combinations and patient populations. About ENDEAVOR The randomized ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial of 929 patients evaluated Kd versus Vd in patients whose multiple myeloma has relapsed after at least one, but not more than three, prior therapeutic regimens. The primary endpoint of the trial was progression free survival, defined as the time from treatment initiation to disease progression or death. The primary analysis was published in The Lancet Oncology and is described in the Prescribing Information. Patients received treatment until progression with KYPROLIS as a 30-minute infusion on days 1, 2, 8, 9, 15 and 16 of 28 day treatment cycles, along with low-dose dexamethasone (20 mg). For Cycle 1 only, KYPROLIS was administered at 20 mg/m2 on days 1 and 2, and if tolerated was escalated to 56 mg/m2 from day 8 of Cycle 1 onwards. Patients who received bortezomib (1.3 mg/m2) with low-dose dexamethasone (20 mg) were treated with bortezomib administered subcutaneously or intravenously at the discretion of the investigator and in accordance with regional regulatory approval of bortezomib. More than 75 percent of the patients in the control arm received bortezomib subcutaneously. Patients were enrolled from 198 sites in 27 countries. For information about this trial, please visit www.clinicaltrials.gov under trial identification number NCT01568866. About Multiple Myeloma Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse.1 It is a rare and very aggressive disease that accounts for approximately one percent of all cancers.2,3 In the U.S., there are nearly 95,000 people living with, or in remission from, multiple myeloma.4 Approximately 30,330 Americans are diagnosed with multiple myeloma each year and 12,650 patient deaths are reported on an annual basis.4 About KYPROLIS® (carfilzomib) Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed.5 KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.5 In some cells, KYPROLIS can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.5,6 KYPROLIS is approved in the U.S. for the following: In combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. KYPROLIS is also approved in Argentina , Australia , Bahrain , Canada , Hong Kong , Israel , Japan , Kuwait , Lebanon , Macao , Mexico , Thailand , Colombia , S. Korea, Canada , Qatar , Switzerland , United Arab Emirates , Turkey , Russia , Brazil , India , Oman and the European Union . Additional regulatory applications for KYPROLIS are underway and have been submitted to health authorities worldwide.
The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).“We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Scott Gottlieb, M.D. “New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses. At the FDA, we’re committed to helping expedite the development and review of groundbreaking treatments that have the potential to be life-saving.”Kymriah, a cell-based gene therapy, is approved in the United States for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse.Kymriah is a genetically-modified autologous T-cell immunotherapy. Each dose of Kymriah is a customized treatment created using an individual patient’s own T-cells, a type of white blood cell known as a lymphocyte. The patient’s T-cells are collected and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill leukemia cells that have a specific antigen (CD19) on the surface. Once the cells are modified, they are infused back into the patient to kill the cancer cells.ALL is a cancer of the bone marrow and blood, in which the body makes abnormal lymphocytes. The disease progresses quickly and is the most common childhood cancer in the U.S. The National Cancer Institute estimates that approximately 3,100 patients aged 20 and younger are diagnosed with ALL each year. ALL can be of either T- or B-cell origin, with B-cell the most common. Kymriah is approved for use in pediatric and young adult patients with B-cell ALL and is intended for patients whose cancer has not responded to or has returned after initial treatment, which occurs in an estimated 15-20 percent of patients.“Kymriah is a first-of-its-kind treatment approach that fills an important unmet need for children and young adults with this serious disease,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “Not only does Kymriah provide these patients with a new treatment option where very limited options existed, but a treatment option that has shown promising remission and survival rates in clinical trials.”The safety and efficacy of Kymriah were demonstrated in one multicenter clinical trial of 63 pediatric and young adult patients with relapsed or refractory B-cell precursor ALL. The overall remission rate within three months of treatment was 83 percent.Treatment with Kymriah has the potential to cause severe side effects. It carries a boxed warning for cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of CAR T-cells causing high fever and flu-like symptoms, and for neurological events. Both CRS and neurological events can be life-threatening. Other severe side effects of Kymriah include serious infections, low blood pressure (hypotension), acute kidney injury, fever, and decreased oxygen (hypoxia). Most symptoms appear within one to 22 days following infusion of Kymriah. Since the CD19 antigen is also present on normal B-cells, and Kymriah will also destroy those normal B cells that produce antibodies, there may be an increased risk of infections for a prolonged period of time.The FDA today also expanded the approval of Actemra (tocilizumab) to treat CAR T-cell-induced severe or life-threatening CRS in patients 2 years of age or older. In clinical trials in patients treated with CAR-T cells, 69 percent of patients had complete resolution of CRS within two weeks following one or two doses of Actemra.Because of the risk of CRS and neurological events, Kymriah is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring that hospitals and their associated clinics that dispense Kymriah be specially certified. As part of that certification, staff involved in the prescribing, dispensing, or administering of Kymriah are required to be trained to recognize and manage CRS and neurological events. Additionally, the certified health care settings are required to have protocols in place to ensure that Kymriah is only given to patients after verifying that tocilizumab is available for immediate administration. The REMS program specifies that patients be informed of the signs and symptoms of CRS and neurological toxicities following infusion – and of the importance of promptly returning to the treatment site if they develop fever or other adverse reactions after receiving treatment with Kymriah.To further evaluate the long-term safety, Novartis is also required to conduct a post-marketing observational study involving patients treated with Kymriah.The FDA granted Kymriah Fast Track, Priority Review and Breakthrough Therapy designations. The Kymriah application was reviewed using a coordinated, cross-agency approach. The clinical review was coordinated by the FDA's Oncology Center of Excellence, while CBER conducted all other aspects of review and made the final product approval determination.The FDA granted approval of Kymriah to Novartis Pharmaceuticals Corp. The FDA granted the expanded approval of Actemra to Genentech Inc.The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.###
Lilly to File Baricitinib Resubmission to U.S. FDA before end of January 2018
PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that, after discussions with the U.S. Food and Drug Administration (FDA) in late August, Lilly will resubmit the New Drug Application (NDA) for baricitinib before the end of January 2018. The resubmission package will include new safety and efficacy data. The companies anticipate the FDA will classify the application as a Class II resubmission, which will start a new six-month review cycle. Baricitinib is a once-daily oral investigational medication for the treatment of patients with moderate-to-severe rheumatoid arthritis (RA)."We are committed to making life better for people living with RA. There is a significant unmet need for Americans suffering from this debilitating disease in spite of available therapies," said Christi Shaw, president of Lilly Bio-Medicines. "We are pleased with the opportunity to provide our resubmission package for baricitinib sooner than anticipated and look forward to continuing to work with the FDA as we seek to bring baricitinib to people with RA in the U.S."About Baricitinib Baricitinib is a once-daily oral JAK inhibitor currently in clinical studies for inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions, including rheumatoid arthritis.In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., the European Union and Japan in 2016. Baricitinib was approved in the EU in February 2017 and in Japan in July 2017. In April 2017, the U.S. Food and Drug Administration issued a Complete Response Letter on the New Drug Application for baricitinib. Baricitinib remains under review in other markets. It is also being studied for the treatment of atopic dermatitis and systemic lupus erythematosus. The Phase 3 program for psoriatic arthritis is expected to begin in 2018.About Rheumatoid Arthritis Rheumatoid arthritis is a systemic autoimmune disease characterized by inflammation and progressive destruction of joints.[i,ii] More than 23 million people worldwide suffer from RA.[iii] Approximately three times as many women as men have the disease. Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs, oral conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), such as methotrexate - the current standard of care - and injectable, biological disease-modifying antirheumatic drugs (bDMARDs) that target selected mediators implicated in the pathogenesis of RA.[iv] Despite current treatment options, many patients do not reach their therapeutic goals or sustained remission.[v,vi] There remains an important need to provide additional treatments to improve overall patient care.About Baricitinib Phase 3 Trials Lilly and Incyte conducted four successful pivotal Phase 3 clinical trials of baricitinib in patients with moderate-to-severe active rheumatoid arthritis to support regulatory submission in most countries. Two of the four studies included pre-specified comparisons to approved DMARDs: one to methotrexate (RA-BEGIN) and one to adalimumab (RA-BEAM). An additional phase 3 study recently concluded to support clinical development in China. The clinical trial program includes a wide range of patients including those who are methotrexate-naïve, inadequate responders to methotrexate, inadequate responders to conventional synthetic disease modifying antirheumatic drugs, or inadequate responders to bDMARDs including TNF inhibitors. Patients completing any of the Phase 3 studies were able to enroll in a long-term extension study. For additional information on this clinical trial program, please visit www.clinicaltrials.gov.About Incyte Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company's web site at www.incyte.com.Follow @Incyte on Twitter at https://twitter.com/Incyte.About Eli Lilly and Company Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.P-LLY This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about baricitinib as a potential treatment for patients with rheumatoid arthritis and reflects Lilly's and Incyte's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that baricitinib will receive regulatory approval or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.i American College of Rheumatology, Rheumatoid Arthritis, http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp. Accessed July 21, 2017. ii Hand Clinics, Advances in the Medical Treatment of Rheumatoid Arthritis, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf. Accessed July 21, 2017. iii WHO Global Burden of Disease Report, (table 7, page 32) 2004, http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf. Accessed July 21, 2017. iv Arthritis Foundation, Medications for Rheumatoid Arthritis, http://www.arthritistoday.org/about-arthritis/types-of-arthritis/rheumatoid-arthritis/treatment-plan/medication-overview/ra-medications.php. Accessed July 21, 2017. v Rheumatoid arthritis, Lancet, https://www.ncbi.nlm.nih.gov/pubmed/27156434. Accessed July 21, 2017. vi Sustained rheumatoid arthritis remission is uncommon in clinical practice, Arthritis Research & Therapy, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446437/. Accessed July 21, 2017.Refer to: Danielle Neveles; email@example.com; +1-317-796-4564 (Lilly media)Phil Johnson; firstname.lastname@example.org; +1-317-655-6874 (Lilly investors)Catalina Loveman; email@example.com; +1-302-498-6171 (Incyte media)Michael Booth, DPhil; firstname.lastname@example.org; +1-302-498-5914 (Incyte investors)
The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria. “The FDA is committed to making new safe and effective antibacterial drugs available,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “This approval provides an additional treatment option for patients with cUTI, a type of serious bacterial infection.”The safety and efficacy of Vabomere were evaluated in a clinical trial with 545 adults with cUTI, including those with pyelonephritis. At the end of intravenous treatment with Vabomere, approximately 98 percent of patients treated with Vabomere compared with approximately 94 percent of patients treated with piperacillin/tazobactam, another antibacterial drug, had cure/improvement in symptoms and a negative urine culture test. Approximately seven days after completing treatment, approximately 77 percent of patients treated with Vabomere compared with approximately 73 percent of patients treated with piperacillin/tazobactam had resolved symptoms and a negative urine culture.The most common adverse reactions in patients taking Vabomere were headache, infusion site reactions and diarrhea. Vabomere is associated with serious risks including allergic reactions and seizures. Vabomere should not be used in patients with a history of anaphylaxis, a type of severe allergic reaction to products in the class of drugs called beta-lactams.To reduce the development of drug-resistant bacteria and maintain the effectiveness of antibacterial drugs, Vabomere should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.Vabomere was designated as a qualified infectious disease product (QIDP). This designation is given to antibacterial products that treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of its QIDP designation, Vabomere received a priority review.The FDA granted approval of Vabomere to Rempex Pharmaceuticals.
New Phase 3 Data for Abemaciclib and Ramucirumab Presented at ESMO 2017 Congress
First presentations of MONARCH 3, a Phase 3 study of abemaciclib as initial treatment for advanced breast cancer, and RANGE, a Phase 3 study of ramucirumab for the treatment of platinum-refractory urothelial cancerINDIANAPOLIS, Aug. 29, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) will showcase new data across six different tumor types at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, September 8-12, 2017. Notably, results from Phase 3 studies of abemaciclib and ramucirumab have been selected for oral presentation during a Presidential Symposium, which features groundbreaking research that is potentially practice-changing, on September 10."In line with this year's theme of 'integrating science into oncology for a better patient outcome,' the data being presented at ESMO demonstrate how we are further developing our foundational medicines - each rooted in the biology of cancer - to deliver innovative breakthrough medicines that will make a meaningful difference to patients and doctors," said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. "We are excited to share new data that shows our progress on bringing forward abemaciclib as a potential new treatment option for advanced breast cancer and investigating the use of ramucirumab in additional tumor types such as advanced or metastatic urothelial carcinoma."For the first time, two Lilly molecules will be featured in an ESMO Presidential Symposium, with data from its MONARCH 3 and RANGE studies in advanced breast cancer and platinum-refractory urothelial cancer, respectively. MONARCH 3 is a global Phase 3, double-blind, placebo-controlled study, which evaluated the efficacy and safety of abemaciclib in combination with a nonsteroidal aromatase inhibitor (letrozole or anastrozole) as initial endocrine-based therapy for postmenopausal women with advanced breast cancer who have had no prior systemic treatment for advanced disease. RANGE is a global Phase 3 randomized, double-blind study evaluating the safety and efficacy of ramucirumab and docetaxel compared to placebo and docetaxel in patients with advanced or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy.All key studies, along with the times and locations of their data sessions, are highlighted below.AbemaciclibAbstract Title: MONARCH 3: Abemaciclib as initial therapy for patients with HR+/HER2- advanced breast cancer Abstract #236O_PR; Presidential Symposium II: Sunday, September 10, 2017; 16:30-16:45 CEST Author/Speaker: Angelo Di Leo, M.D., Hospital of Prato, Instituto Toscano Tumori Location: Madrid AuditoriumAbstract Title: Efficacy and Safety of Abemaciclib Combined with LY3023414 or Pembrolizumab in Stage IV NSCLC Abstract #1363P; Poster Session: Saturday, September 9, 2017; 13:15-14:15 CEST Author/Speaker: Pilar Garrido Lopez, M.D., Hospital Universitario Ramón y Cajal Location: Hall 8Abstract Title: Analysis of overall survival by tumor response in MONARCH 1, a phase 2 study of abemaciclib, a CDK4 and CDK6 inhibitor, in women with HR+/HER2- metastatic breast cancer (MBC) after chemotherapy for advanced disease Abstract #249P; Poster Session: Monday, September 11, 2017; 13:15-14:15 CEST Author/Speaker: Javier Cortés, M.D., Vall d'Hebron University Hospital Location: Hall 8Abstract Title: Abemaciclib plus fulvestrant in patients (pts) with HR+/HER2- endocrine therapy naïve (EN) advanced breast cancer - an exploratory analysis of MONARCH 2 Abstract #253P; Poster Session: Monday, September 11, 2017; 13:15-14:15 CEST Author/Speaker: Peter Kaufman, M.D., Dartmouth-Hitchcock Medical Center Location: Hall 8 RamucirumabAbstract Title: RANGE: a randomized, double-blind, placebo-controlled phase 3 study of docetaxel (DOC) with or without ramucirumab (RAM) in platinum-refractory advanced or metastatic urothelial carcinoma Abstract #LBA4; Presidential Symposium II: Sunday, September 10, 2017; 17:30-17:45 CEST Author/Speaker: Daniel Petrylak, M.D., Yale Cancer Center Location: Madrid AuditoriumAbstract Title: Meta-analysis of individual patient safety data from six randomized, placebo-controlled trials with the antiangiogenic VEGFR2-binding monoclonal antibody ramucirumab Abstract #1592P; Poster Session: Sunday, September 10, 2017; 13:15-14:15 CEST Author/Speaker: Dirk Arnold, M.D., Klinik für Tumorbiologie Location: Hall 8Abstract Title: A Dose-Response Study of Ramucirumab Treatment in Patients with Gastric Cancer/Gastroesophageal Junction Adenocarcinoma: Primary Results of 4 Dosing Regimens in the Phase 2 Trial I4T-MC-JVDB Abstract #698P; Poster Session: Saturday, September 9, 2017; 13:15-14:15 CEST Author/Speaker: Jaffer Ajani, M.D., MD Anderson Cancer Center Location: Hall 8Abstract Title: Analysis of Angiogenesis Biomarkers for Ramucirumab (RAM) Efficacy in Patients with Metastatic Colorectal Cancer (mCRC) from RAISE, a Global, Randomized, Double-Blind, Phase 3 Study Abstract #555P; Poster Session: Saturday, September 9, 2017; 13:15-14:15 CEST Author/Speaker: Josep Tabernero, M.D., Vall d'Hebron University Hospital Location: Hall 8 SarcomaAbstract Title: The Sarcoma Policy Checklist - focusing policy efforts on sarcoma Abstract #1493P; Poster Session: Monday, September 11, 2017; 13:15-14:15 CEST Author/Speaker: Bernd Kasper, M.D., Universitätsmedizin Mannheim Location: Hall 8 Notes to EditorAbout Lilly Oncology For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. To learn more about Lilly's commitment to people with cancer, please visit www.LillyOncology.com.About Eli Lilly and Company Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/newsroom/social-channels. P-LLY© Lilly USA, LLC 2017. ALL RIGHTS RESERVED.Lilly Forward-Looking Statement This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about abemaciclib as a potential treatment for patients with breast cancer and ramucirumab as a potential treatment for patients with treatment of platinum-refractory urothelial cancer, and reflects Lilly's current beliefs. However, as with any pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that abemaciclib or ramucirumab will receive regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.Refer to: Erin Graves; email@example.com; 908-541-8257 (media)Phil Johnson; firstname.lastname@example.org; 317-655-6874 (investors)
New Analysis Shows Repatha® (Evolocumab) Reduces Cardiovascular Events In Patients With History Of Stroke
PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that a new analysis showed lowering low-density lipoprotein cholesterol (LDL-C) levels with Repatha® (evolocumab) reduced the risk of cardiovascular events in a sub-group of patients with a history of stroke from the Repatha cardiovascular outcomes study (FOURIER). No new safety concerns were identified in this cohort of more than 5,000 patients. Detailed results were presented today in a Late-Breaking Clinical Trials session at the European Society of Cardiology (ESC) Congress 2017 in Barcelona, Spain . "The clinical benefits of PCSK9 inhibition in stroke patients have not been previously reported. The reduction in cardiovascular event risk in this analysis is similar to what we saw in the broader 27,564-patient FOURIER study, supporting Repatha's role in reducing the risk of future cardiovascular events for patients with a history of stroke," said Terje Pedersen , professor emeritus, Department of Endocrinology , Morbid Obesity and Preventive Medicine at the University of Oslo Institute of Clinical Medicine, Oslo, Norway . Nineteen percent of patients in the Repatha cardiovascular outcomes study had a prior history of non-hemorrhagic stroke (n=5,337). In this analysis, stroke patients treated with Repatha experienced a 56 percent mean reduction in LDL-C levels, compared to placebo (median LDL-C level of 29 mg/dL for patients on Repatha versus median LDL-C of 89 mg/dL for placebo; p<0.001). In this analysis, the hazard ratio of Repatha compared to placebo for the composite primary endpoint, which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death, was 0.85 (95 percent CI, 0.72-1.00; p=0.047). The hazard ratio of Repatha compared to placebo for the secondary composite endpoint of heart attack, stroke or cardiovascular death was 0.89 (95 percent CI, 0.74-1.08). The hazard ratios of Repatha compared to placebo for coronary revascularization, heart attack, stroke and cardiovascular death were 0.68 (95 percent CI, 0.52-0.90), 0.74 (95 percent CI, 0.55-1.00), 0.90 (95 percent CI, 0.68-1.19) and 1.11 (95 percent CI, 0.80-1.56), respectively. "The cardiovascular outcomes study FOURIER unequivocally showed that lowering LDL-C with Repatha results in a powerful risk reduction for patients at high risk of a cardiovascular event," said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen . "The fact that we were able to detect a meaningful reduction in the risk of cardiovascular events in the much smaller sub-group of stroke patients is remarkable and demonstrates the importance of the intensive LDL-C lowering Repatha provides for patients with established atherosclerotic cardiovascular disease." In the sub-group of patients with a history of stroke, there were no notable differences in the overall rate of adverse events, serious adverse events or adverse events leading to study drug discontinuation. Rates of adjudicated new onset diabetes (2.1 percent Repatha; 2.0 percent placebo), cataract (1.0 percent Repatha; 0.8 percent placebo), and neurocognitive adverse events (1.0 percent Repatha; 1.0 percent placebo) were similar between the two arms. Primary Analysis of the Repatha Cardiovascular Outcomes Trial The primary analysis included 27,564 patients with established cardiovascular disease. The study was statistically powered around the hard major adverse cardiovascular event (MACE) composite endpoint of first heart attack, stroke or cardiovascular death (key secondary composite endpoint) and found that adding Repatha to optimized statin therapy resulted in a statistically significant 20 percent (p<0.001) reduction in these events. The study also found a statistically significant 15 percent reduction (p<0.001) in the risk of the extended MACE composite (primary) endpoint, which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death. No new safety concerns were identified in this large clinical trial with roughly 60,000 patient-years of follow-up; this included the assessment of patients who achieved very low levels of low-density lipoprotein cholesterol (LDL-C). The detailed results from the Repatha cardiovascular outcomes study were initially presented during a Late-Breaking Clinical Trials Session at the American College of Cardiology 66th Annual Scientific Session and simultaneously published in the New England Journal of Medicine . Repatha Cardiovascular Outcomes (FOURIER) Study Design The 27,564-patient Repatha cardiovascular outcomes study, FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), was a multinational Phase 3 randomized, double-blind, placebo-controlled trial, designed to evaluate whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces cardiovascular events. The primary endpoint was time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary endpoint was the time to cardiovascular death, myocardial infarction or stroke. Eligible patients with high cholesterol (LDL-C =70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] =100 mg/dL) and clinically evident atherosclerotic cardiovascular disease at more than 1,200 study locations around the world were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly plus optimized statin dose; or placebo subcutaneous every two weeks or monthly plus optimized statin dose. Optimized statin therapy was defined as at least atorvastatin 20 mg or equivalent daily with a recommendation for at least atorvastatin 40 mg or equivalent daily where approved. The study was event driven and continued until 1,630 patients experienced a key secondary endpoint.
The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease. Chagas disease, or American trypanosomiasis, is a parasitic infection caused by Trypanosoma cruzi and can be transmitted through different routes, including contact with the feces of a certain insect, blood transfusions, or from a mother to her child during pregnancy. After years of infection, the disease can cause serious heart illness, and it also can affect swallowing and digestion. While Chagas disease primarily affects people living in rural parts of Latin America, recent estimates are that there may be approximately 300,000 persons in the United States with Chagas disease.“The FDA is committed to making available safe and effective therapeutic options to treat tropical diseases,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.The safety and efficacy of benznidazole were established in two placebo-controlled clinical trials in pediatric patients 6 to 12 years old. In the first trial, approximately 60 percent of children treated with benznidazole had an antibody test change from positive to negative compared with approximately 14 percent of children who received a placebo. Results in the second trial were similar: Approximately 55 percent of children treated with benznidazole had an antibody test change from positive to negative compared with 5 percent who received a placebo. An additional study of the safety and pharmacokinetics (how the body absorbs, distributes and clears the drug) of benznidazole in pediatric patients 2 to 12 years of age provided information for dosing recommendations down to 2 years of age.The most common adverse reactions in patients taking benznidazole were stomach pain, rash, decreased weight, headache, nausea, vomiting, abnormal white blood cell count, urticaria (hives), pruritus (itching) and decreased appetite. Benznidazole is associated with serious risks including serious skin reactions, nervous system effects and bone marrow depression. Based on findings from animal studies, benznidazole could cause fetal harm when administered to a pregnant woman.Benznidazole was approved using the Accelerated Approval pathway. The Accelerated Approval pathway allows the FDA to approve drugs for serious conditions where there is unmet medical need and adequate and well-controlled trials establish that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. Further study is required to verify and describe the anticipated clinical benefit of benznidazole.The FDA granted benznidazole priority review and orphan product designation. These designations were granted because Chagas disease is a rare disease, and until now, there were no approved drugs for Chagas disease in the United States.With this approval, benznidazole’s manufacturer, Chemo Research, S. L., is awarded a Tropical Disease Priority Review Voucher in accordance with a provision included in the Food and Drug Administration Amendments Act of 2007 that aims to encourage development of new drugs and biological products for the prevention and treatment of certain tropical diseases.The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.