FDA says no to Novartis heart drug

Share this article:
Novartis announces good heart drug results
Novartis announces good heart drug results

The FDA hit drugmaker Novartis with a setback Friday, rejecting the company's experimental acute heart-failure drug serelaxin through a Complete Response Letter.

Novartis announced the CRL Friday, saying the US regulator wanted more efficacy information than the Phase-II and Phase-III safety and efficacy data that accompanied the filing.

Although the FDA does not have to adhere to advisory panel recommendations, Friday's news synchs with an FDA panel's March vote against the drug, which rang in at 11-0.

Novartis is not giving up on the drug, despite Friday's announcement and the European Medicines
Agency's rejection in January. Instead, the company said it will expand the data set with a patient pool that will ultimately include 6,300 patients worldwide.

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

Next Article in News

Email Newsletters

More in News

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, ...

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.