FDA To Review Heart Failure Drug For Approval
The FDA announced a new plan to review and evaluate Serelaxin, a new injection based medication by Novartis, designed to treat heart failure. The FDA’s Cardiovascular and Renal Drugs Advisory Committee will begin reviewing the drug, including its Biologics License Application (BLA), on February 13, 2014. A notice for the planned review is available for viewing on the Federal Register, however, the FDA has yet to post the information on their website.
Serelaxin is the product of genetically engineering the hormone Relaxin-2, a hormone that occurs naturally in humans and is designed to reduce the rate of the progression of heart failure by improving the patient’s symptoms. In 2013, Serelaxin received the breakthrough therapy designation by the FDA.
The majority of information currently available about Serelaxin came from the RELAX-AHF trial published by Lancet in 2013. Although the initial trial produced safe results, the FDA will evaluate whether or not another trial should be done for Serelaxin as the RELAX-AHF trial is not enough to warrant a firm decision on whether the results were a product of an efficient drug or a chance improvement within a small test group. Milton Packer, M.D., stated “If the mortality effect is true then this trial changes the way we do things” but went on to express “the real question is whether the mortality difference seen in this trial is true and replicable.”
The review is meant to eliminate any doubt as to whether or not the trial was enough to warrant approval by the FDA and become the first true significant treatment for heart failure. Similar results via a trial were achieved by Johnson & Johnson for Natrecor. For almost 10 years, Natrecor was considered a safe treatment for acute heart failure. However, the final results of the ASCEND-HF trial published in 2011 concluded that the drug was not safe for routine use and eventually criminal charges were filed against Scios Inc., a subsidiary of J&J.