Serelaxin regulatory update

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 11-0 against approval of serelaxin from Novartis to treat acute heart failure (AHF) due to inconsistent evidence of efficacy. It was the sole voting question for the recombinant human relaxin 2 ( RLN2; H2). The PDUFA date is May 17.

In the Phase III RELAX-AHF trial, serelaxin met the co-primary endpoint of an improvement in patient reported dyspnea using the visual analog scale (VAS), but missed the co-primary endpoint of moderate or markedly better dyspnea relative to baseline using the 7-point Likert scale. The trial was the only Phase III trial included in the BLA. ...