FDA panel votes no on Novartis heart failure drug
An FDA advisory panel voted against approving Novartis acute heart failure drug serelaxin today, according to a briefing document posted on the regulator's website.
“We recommend that seralaxin not be approved at this time because 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,'” reviewers Melanie Blank, MD, and Tzu-Yun McDowell stated.
Novartis affirmed its position on the product in a statement to Reuters, noting that seralaxin “demonstrates a clinically significant beneficial effect in patients with AHF, with an overall favorable benefit-risk profile.”
The results submitted to FDA were based on one study, which showed that the drug reduced deaths by 37% compared with patients in a control group after six months of treatment. FDA reviewers stated, however, that the data did not take cough, choking, fatigue or anxiety as symptoms of acute heart failure into account.
“Therefore, the current evidence does not support a broad claim related to the symptoms of acute heart failure,” reviewers wrote. FDA is scheduled to make a decision on serelaxin's approval by May 17.