Amgen's Ivabradine Fast Tracked By FDA For Chronic HF

Amgen announced that its investigational drug Ivabradine has received fast track status from the U.S. Food and Drug Administration (FDA) for patients with chronic heart failure (HF).

Ivabradine is a selective inhibitor of hyperpolarisation-activated cyclic-nucleotide-gated funny current (If), which plays a role in pacemaking-generation and responsiveness of the sinoatrial node, the body’s cardiac pacemaker, resulting in heart-rate reduction. The drug was approved under brand name Procoralan by the European Medicines Agency (EMA) in 2005 for the symptomatic treatment of stable angina and again in 2012 for chronic HF in patients with elevated heart rates.

Heart failure affects an estimated 26 million people around the world, including about 5.1 million in the U.S. Prognosis is poor for most patients with HF in spite of currently available treatments. By 2030, prevalence of heart failure is projected to increase by 25 percent from 2013 estimates.

The company said the designation is an important milestone and that it will work closely with the FDA to secure its approval for patients with chronic HF in the U.S. Fast track designation facilitates the development and expedited review of a drug with potential to treat serious conditions and fill unmet medical needs. The designation grants drug sponsors with eligibility for priority review and more frequent meetings with the FDA. The status also grants rolling review if relevant criteria are met. A rolling review allows a drug company to submit completed sections of its Biological License Application (BLA) or New Drug Application (NDA) even before all sections of the application are completed. However, Fast Track designation does not change the time clock for the FDA’s approval.

The company secured rights to commercialize Ivabradine in the U.S. through collaboration with the drug’s developer Servier. Amgen announced that it plans to file for FDA approval in the second quarter of 2014.