Novartis defends mixed Phase III results for heart failure drug serelaxin
This article was originally published in Scrip
Executive Summary
Serelaxin (RLX030) significantly reduced dyspnea, or shortness of breath, and the number of deaths associated with acute heart failure (AHF) was 37% lower than in the Phase III RELAX-AHF study's placebo arm, but analysts were skeptical about the Novartis drug's chances for approval based on mixed data for primary and secondary endpoints in the 1,161-patient clinical trial.