Reasanz serelaxin regulatory update

EMA's CHMP confirmed a January negative opinion recommending against approval of Reasanz serelaxin from Novartis to treat acute heart failure (AHF). The committee reviewed again the data from the 1,161-patient Phase III RELAX-AHF trial and confirmed its opinion that the effectiveness of Reasanz had not been demonstrated. Novartis had requested a re-examination of the January negative opinion (see BioCentury, Jan. 27).

Earlier this month, FDA issued a complete response letter for a BLA for the recombinant human relaxin 2 ( RLN2; H2) (see BioCentury, May 19). The pharma plans to resubmit the MAA to EMA and BLA to FDA with data from the Phase III RELAX-AHF-2 trial of serelaxin as soon as data are available. Data from the trial are expected in 2H16, with an interim analysis slated for next year. Serelaxin has breakthrough therapy designation from FDA for AHF. ...