Amgen Statement on FDA Fast Track Designation for Investigational Ivabradine
The U.S. Food and Drug Administration (FDA) has granted fast track designation for investigational ivabradine for patients with 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 The designation is an important milestone and Amgen looks forward to working closely with the FDA to potentially bring this treatment option to patients with chronic HF in the U.S.
Fast track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The designation allows for such options as eligibility for priority review, if relevant criteria are met, more frequent meetings with FDA, and rolling review, which means that a drug company can submit completed sections of its Biological License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. The BLA or NDA review otherwise usually does not begin until the drug company has submitted the entire application to the FDA. Fast track designation does not change the Prescription Drug User Fee Act (PDUFA) approval date or time clock for the FDA to approve a drug.2
Through a collaboration with Servier, Amgen has rights to commercialize ivabradine in the U.S. and plans to file for FDA approval in Q2 2014. Developed by 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 HF in patients with elevated heart rates.
About 26 million people have HF worldwide, including approximately 5.1 million people in the U.S.3,4 Projections show that by 2030, the prevalence of HF will increase 25 percent from 2013 estimates.4 Despite currently available treatments, prognosis is poor.4,5
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1. 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.
2. 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 April 2014.
3. López-Sendón, J. The heart failure epidemic. MEDICOGRAPHIA. 2011;33(4):363-369.
4. Go, AS et al. Heart Disease and Stroke Statistics--2013 Update: A Report From the American Heart Association. Circ. 2013;127:e6-e245.
5. National Heart, Lung, and Blood Institute. What is Heart Failure? Available at: http://www.nhlbi.nih.gov/health/health-topics/topics/hf/. Accessed April 2014.