In comments made in briefing documents
posted prior to today’s meeting of the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee
, reviewers recommended against approval for Novartis’ proposed novel acute heart failure (AHF) drug serelaxin injection, which was designated a “breakthrough therapy” by the FDA less than a year ago.
Although the reviewers did not cite specific safety concerns as a reason for their opposition, and noted that the “favorable 180-day mortality data for serelaxin is reassuring,” they concluded “there is insufficient evidence to support the proposed indication: to ‘improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure.’”
Novartis’ biologics license application (BLA) for serelaxin injection is based on the RELAX-AHF trial, published in the Lancet.
In the study, 1,161 patients were randomized to receive serelaxin or placebo for the first 48 hours of acute decompensated heart failure.
Compared to placebo, serelaxin was associated with a 19.4% improvement of dyspnea relief through day 5, although there was no difference between the groups in dyspnea relief at 24 hours. There were also no significant differences between groups in cardiovascular death or hospital readmission for heart failure or renal failure through day 60. However, cardiovascular deaths at 6 months were significantly reduced in the serelaxin group.
The panel meeting today does not include many of the critics who have been most vocal. Novartis’ speaker is a former chair of the advisory panel.