FDA gives nod to Amgen’s Heart-Failure Treatment Corlanor
Amgen's heart-failure treatment Corlanor has got a green signal from the US Food and Drug Administration. The drug was designated for priority review in August.
The drug is believed to have high efficacy of regulating heart rate and reducing the risk of hospitalization for worsening heart failure. The drug is meant for patients with stable, chronic heart failure caused by a poorly-contracting lower-left part of the heart.
The drug is an oral medication and the FDA has approved it as the first new chronic heart-failure medicine in nearly a decade. Each year, an estimated $31 billion comes as cost of heart failure in the US, as per the company. Majority of the cost is associated with hospitalizations.
Approximately 5.7 million people are affected by the condition in the US and half of them have reduced left ventricular function, said the FDA in a statement.
Corlanor was found to have reduced the risk of hospitalization or cardiovascular death for worsening heart failure by 18% in a 6,500-patient study. The drug yielded great results, majorly by reducing hospitalization.
Sean Harper, Amgen's head of research and development, said heart-failure doctors at some point feels the need of doing something more to these patients.
Fast-track status was first granted by the FDA for the drug last April and the priority review designation was assigned four months later.
Drugs that are intended to treat serious conditions get priority review status. The drug was approved by the European Medicines Agency in 2005 to treat stable angina. The drug was later approved in 2012 to treat chronic heart failure.
"Heart failure is a leading cause of death and disability in adults. Corlanor ... represents the first approved product in this drug class", said Norman Stockbridge, director of FDA's Division of Cardiovascular and Renal Products.