FDA Rejects Novartis Heart Drug
Reuters reports that the U.S. Food and Drug Administration (FDA) has denied approval for Novartis' experimental heart failure drug, serelaxin, due to lack of proven efficacy.
About the FDA's Decision on Serelaxin
Serelaxin, also called RLX030, is being developed by Novartis as a treatment for acute heart failure and was considered a potential “blockbuster” for the company as it attempts to strengthen its heart drug portfolio.
However, serelaxin encountered trouble in March when members of a FDA advisory panel voted unanimously against approval for the drug, claiming that there was a lack of evidence proving the medications benefits outweigh potential risks.
According to Novartis, the FDA sided with the advisers, asking for further evidence to determine the efficacy of the drug.
Reports indicate that Novartis will continue development for serelaxin and will be pursuing additional clinical trials. The company has already announced plans for a 6,300 patient trial.
Heart Failure Statistics
- According to Novartis, there are roughly five million people living with chronic heart failure in the U.S. Along.
- Chronic heart is a progressive disease in which the heart loses its ability to pump enough blood through the body, depriving organs and tissues of the oxygen and nutrients needed to function properly.
- Nearly 10 in every 1,000 people over the age of 65 have developed chronic heart failure, and 400,000 new cases are identified every year.