Amgen Inc. (AMGN) received encouraging news from the FDA as the regulatory body granted priority review status to the New Drug Application (:NDA) for its pipeline candidate, ivabradine. Amgen is looking to get ivabradine approved for the treatment of chronic heart failure.
We note that the FDA grants priority review status to candidates which have the potential to bring significant improvements in terms of safety or effectiveness in the treatment, diagnosis or prevention of serious diseases when compared to currently available therapies. Priority review means the FDA will provide a response on the approval status of the candidate within six months of receiving the regulatory application.
We remind investors that the NDA was submitted by Amgen in July this year. This means a response from the FDA should be out early next year.
According to the press release issued by Amgen, heart failure affects nearly 26 million people across the world including 5.1 million in the U.S. alone. Approximately 2.5 million people in the U.S. die within five years of diagnosis. The approval of ivabradine will provide significant benefit to the eligible patient population in the U.S.
Amgen also has fast track designation for ivabradine.
Amgen has a licensing agreement with Servier, a privately-run French research-based pharmaceutical company, for ivabradine under which Amgen will commercialize ivabradine in the U.S. Ivabradine is currently approved in the EU under the trade name Procoralan, for stable angina and chronic heart failure in patients with elevated heart rates.