BioCentury
ARTICLE | Company News

Complete response for Novartis' serelaxin

May 17, 2014 12:18 AM UTC

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA issued a complete response letter for a BLA for serelaxin ( RLX030) to treat acute heart failure (AHF). According to the pharma, the agency said further evidence of serelaxin's efficacy is required for approval. In March, FDA's Cardiovascular and Renal Drugs Advisory Committee voted 11-0 against approval of serelaxin, citing inconsistent efficacy evidence in the Phase III RELAX-AHF trial, the single Phase III trial included in the BLA (see BioCentury, April 7). ...