BioCentury
ARTICLE | Clinical News

Serelaxin regulatory update

January 27, 2014 8:00 AM UTC

EMA's CHMP recommended against approval of Reasanz serelaxin from Novartis to treat acute heart failure (AHF). The committee said the safety of serelaxin "seemed acceptable" but that because of uncertainties about serelaxin's benefits, the compound's benefits do not outweigh its risks. CHMP noted that serelaxin did not show short-term relief of dyspnea and that while serelaxin did relieve dyspnea over 5 days, the clinical relevance for AHF was not clear. CHMP also noted that Novartis' analyses did not include data from patients who had died or required additional treatment and questioned whether differences in background therapy influenced the data.

The MAA for serelaxin is based on the 1,161-patient Phase III RELAX-AHF trial (see BioCentury, Nov. 12, 2012). Novartis said it plans to submit and request a reexamination of a revised application that includes new analyses to seek conditional approval of serelaxin in the EU. The original application was reviewed for standard approval. An FDA advisory committee is scheduled to meet on Feb. 13 to discuss the recombinant human relaxin 2 ( RLN2; H2), which is under review and has breakthrough therapy designation from the agency for AHF. ...