US FDA advisory panel votes against approval of Novartis’ AHF drug

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee (CRDAC) yesterday voted unanimously (11-0) against approval for Swiss pharma major Novartis’ (NOVN: VX) RLX030 (serelaxin) for the treatment of acute heart failure (AHF).

The vote was in line with briefing papers released earlier this week by FDA staff, suggesting the relaxin receptor agonist should not be approved because there is "insufficient evidence" to support the proposed indication.

Data presented at the Advisory Committee meeting included Phase II and III efficacy and safety data from the RLX030 clinical development program, including the pivotal Phase III RELAX-AHF study, said Novartis. In this study RLX030 improved the symptoms of acute heart failure (AHF) through reducing the rate of worsening heart failure, a measure of symptom deterioration that requires intensification of therapy.