FDA Advisory Panel Votes Down Approval for Novartis’ Serelaxin

Novartis reports that FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted against approval for RLX030 (serelaxin) for the treatment of acute heart failure (AHF).

RLX030 is under review to improve the symptoms of AHF through reduction of the rate of worsening of heart failure. Its proposed administration is in addition to conventional therapies, as a 48-hour infusion in the hospital during an AHF episode. The recommendation of the Advisory Committee will be considered by the FDA in its review of the biologics license application (BLA) for RLX030, but the FDA is not bound to follow them. The FDA makes the final decision on approvals of new treatments.

RLX030, a relaxin receptor agonist, is a recombinant form of a naturally occurring hormone (human relaxin 2) present in both men and women. RLX030 was granted Breakthrough Therapy (BT) designation status by the FDA in June 2013 for the ongoing development program. The BT designation is independent of the BLA currently under review and its corresponding FDA action date. The ongoing development program includes RELAX-AHF-2, a global, Phase III outcomes study of more than 6300 patients, of which approximately 1000 will be from the US. The study began recruiting in 2013; results are expected in 2016 and will add to the current body of evidence for RLX030.

Source: Novartis

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