BioCentury
ARTICLE | Clinical News

Procoralan ivabradine regulatory update

April 20, 2015 7:00 AM UTC

FDA approved an NDA from Amgen Inc. (NASDAQ:AMGN, Thousand Oaks, Calif.) for Corlanor ivabradine to treat chronic heart failure (CHF). Amgen, which made the announcement on April 15, plans to launch the selective If channel inhibitor within 1 week at a wholesale acquisition price of $375 per month. Specifically, Corlanor is indicated to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic CHF with left ventricular ejection fraction <=35% who are in sinus rhythm with resting heart rate >=70 beats per minute and either are on maximally tolerated doses of beta blockers or have a contraindication to beta blocker use. ...