FDA Grants Amgen Priority Review Designation For Ivabradine For The Treatment Of Chronic Heart Failure
THOUSAND OAKS, Calif., Aug. 27, 2014 /PRNewswire/ -- Amgen today announced the U.S. Food and Drug Administration (FDA) has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the If current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.1 Ivabradine works to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization.1 Heart failure is a common condition that affects approximately 26 million worldwide, including approximately 5.1 million people in the U.S.2,3
"The priority review designation by the FDA is evidence that chronic heart failure is a serious condition, which leads to high rates of rehospitalization and poor prognosis despite available treatments. If approved, ivabradine would potentially provide a significant improvement, on top of standard-of-care therapies, for this grievous condition," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are excited about the opportunity to bring this important therapeutic option to certain patients with chronic heart failure in the U.S."
The New Drug Application (NDA) is based on global clinical trial data from the Phase 3 SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) study, a large, multi-center, randomized, double-blind, placebo-controlled, outcomes trial. The pivotal SHIFT study compared ivabradine to placebo on top of standard-of-care therapies, including beta-blockers, in more than 6,500 patients in sinus rhythm with reduced left ventricular function and heart rate >70 beats per minute (bpm).
Priority review designation is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies. A priority review designation will set a goal date for taking action on an application within six months of receipt.4
In addition, in April 2014, the FDA granted fast track designation for ivabradine for patients with chronic HF. A fast track designation is a process intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Products that have been designated as fast track can submit portions of a marketing application before submitting the complete application, known as rolling review.5
Heart failure is the leading cause of rehospitalization in Medicare beneficiaries over age 55,6 and approximately 50 percent of people diagnosed with HF in the U.S. die within five years of diagnosis.3 Projections show that by 2030, the prevalence of HF will increase 25 percent from 2013 estimates.3 Despite broad use of standard treatments, the prognosis for HF is poor.7
Ivabradine is an investigational oral drug that inhibits the If current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.1 Ivabradine works to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization.1 Developed by Les Laboratoires Servier, ivabradine was approved by the European Medicines Agency (EMA) as PROCORALAN® in 2005 for the symptomatic treatment of stable angina and in 2012 for chronic heart failure (HF) in patients with elevated heart rates. Through a collaboration with Servier, Amgen has rights to commercialize ivabradine in the U.S.
About Amgen's Commitment to Cardiovascular Disease
Amgen is dedicated to addressing important scientific questions in order to advance care and improve the lives of patients with cardiovascular disease. Through its own research and development efforts and innovative partnerships, Amgen has built a robust cardiology pipeline consisting of several investigational molecules in an effort to address a number of today's important unmet patient needs, such as high cholesterol and heart failure.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Aug. 27, 2014, and expressly disclaims any duty to update information contained in this news release.
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- DiFrancesco D and Camm JA. Heart Rate Lowering by Specific and Selective I(f) Current Inhibition With Ivabradine: a New Therapeutic Perspective in Cardiovascular Disease. Drugs. 2004;64(16):1757–1765.
- López-Sendón, J. The Heart Failure Epidemic. MEDICOGRAPHIA. 2011;33(4):363-369.
- Go AS, Mozaffarian D, Roger VL, et al. Heart Disease and Stroke Statistics--2013 Update: A Report From the American Heart Association. Circ. 2013;127:e6-e245.
- U.S. Food and Drug Administration. Center for Drug Evaluation and Research MAPP 6020.3. http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/manualofpoliciesprocedures/ucm082000.pdf. Accessed August 2014.
- Food and Drug Administration. For Consumers: Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review. Available at: http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm. Accessed August 2014.
- Jencks SF, Williams M, Coleman E. Rehospitalizations among Patients in the Medicare Fee-for-Service Program. NEJM. 2009;360:1418-28.
- Swedberg K, Komajda M, Böhm M, et al. Ivabradine and Outcomes in Chronic Heart Failure (SHIFT): a Randomised Placebo Controlled Study. Lancet. 2010;376:875-85.
Posted: August 2014