US FDA stalls approval of Novartis acute heart failure drug serelaxin, issuing a CRL

The US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RLX030 (serelaxin) for the treatment of acute heart failure (AHF), stating that further evidence on the efficacy of RLX030 is required for a US license to be granted, the drug’s developer, Swiss pharma major Novartis (NOVN: VX), revealed this morning.

The FDA’s decision comes after its Cardiovascular and Renal Drugs Advisory Committee (CRDAC) earlier this year voted unanimously (11-0) against approval of serelaxin - previously granted Breakthrough Therapy designation - for the treatment of AHF (The Pharma Letter March 28). The drug - proposed trade name is Reasanz – also failed to win backing from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) which questioned the drug’s efficacy (TPL January 24). If approved, serelaxin could generate $523 million in sales in 2018, based on the average of eight analysts’ estimates compiled by Bloomberg.

Company will continue clinical program