FDA panel votes no on Novartis heart failure drug

Share this article:

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.

Share this article:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Illumina inks deal with J&J, AstraZeneca, Sanofi

The goal is to develop companion diagnostics to match patients with cancer treatments.

Abbott deal highlights inversion inaction

Political furor over the recent spate of tax inversions is having little influence on how the government chooses its partners.

Allergan reported to seek out Salix deal

The Wall Street Journal says the deal would add "another layer of intrigue" to the Allergan-Valeant hostilities.