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ARTICLE | Company News

Advisory panel snubs serelaxin

March 28, 2014 12:50 AM UTC

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 11-0 against approval of serelaxin ( RLX030) from Novartis AG (NYSE:NVS; SIX:NOVN) to treat acute heart failure (AHF) due to inconsistent evidence of efficacy. The PDUFA date for the recombinant human relaxin 2 ( RLN2; H2) 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 seven-point Likert scale. The trial was the only Phase III trial included in the BLA. ...