FDA postpones serelaxin meeting

FDA postponed Thursday's meeting of its Cardiovascular and Renal Drugs Advisory Committee, which was set to discuss a BLA from Novartis AG (NYSE:NVS; SIX:NOVN) for serelaxin ( RLX030) to treat acute heart failure (AHF). The meeting was postponed due to weather; a new date has not yet been set. The recombinant human relaxin 2 (RLN2; H2) has FDA breakthrough therapy designation for the indication.

Last month, EMA's CHMP recommended against approval of serelaxin to treat AHF, citing uncertainties about serelaxin's benefits. Novartis said it plans to submit and request a reexamination of a revised application that includes new analyses (see BioCentury Extra, Jan. 24). ...