WASHINGTON, DC — Serelaxin (RLX030, Novartis) failed to meet its primary end points in acute heart failure in the RELAX-AHF-2 study, putting its future in jeopardy.
An update of the phase 3 data showed serelaxin did not significantly reduce the rate of cardiovascular death through day 180 or worsening heart failure through day 5 in acute heart-failure patients when added to standard therapy, according to the company[1].
The first-in-class recombinant form of human hormone relaxin 2 reduced dyspnea in the RELAX-AHF trial but questions about its mortality benefit remained.
The drug was subsequently shot down for the treatment of acute HF in 2014 by US Food and Drug Administration reviewers, who cited insufficient evidence to support approval, and by European Medicines Agency reviewers, who acknowledged the safety of the drug but also cited uncertainties about its benefits.
It was hoped that the Novartis-sponsored RELAX-AHF-2, which began in 2013 and included 6600 patients hospitalized for acute HF, would provide that additional support.
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Heartwire from Medscape © 2017
Cite this: Serelaxin Again Bombs in Acute Heart Failure: RELAX-AHF-2 - Medscape - Mar 23, 2017.
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