BioCentury
ARTICLE | Clinical News

Serelaxin regulatory update

May 19, 2014 7:00 AM UTC

Novartis said FDA issued a complete response letter for a BLA for serelaxin to treat acute heart failure (AHF). According to the pharma, the agency said further evidence of efficacy of serelaxin 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, March 31). The pharma said it plans to resubmit the BLA with data from the ongoing Phase III RELAX-AHF-2 trial of serelaxin and "will evaluate resubmission timelines as RELAX-AHF-2 progresses." Data from the trial are expected in 2H16, with an interim analysis slated for next year. Novartis has breakthrough therapy designation from FDA for serelaxin on the basis of a mortality benefit in the RELAX-AHF trial. In January, EMA's CHMP recommended against approval of serelaxin to treat AHF, citing uncertainties about serelaxin's benefits (see BioCentury, Jan. 27). ...