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:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies

Kantar acquires Evidências, expands Brazilian presence

The company's acquisition signals the growing importance of understanding the Brazilian healthcare market and evidence-based healthcare management services.

Study says statins not enough for diabetic hearts

Researchers using an experimental test have discovered that the 50% of surveyed diabetics may also have undetected heart muscle damage.