Novartis' experimental heart failure medication, serelaxin, shouldn’t be approved for sale, an FDA in-house review said, potentially dealing a blow to one of Novartis' top late-stage prospects.
In advance of the FDA advisory committee meeting, which is scheduled for Thurday, March 27th, the FDA has stated that there is insufficient evidence to support Novartis’s claim that serelaxin helps prevent worsening of the disease that causes the heart to malfunction.
FDA concerns surrounded the fact that Novartis only presented a single trial and the significance of the benefit was not sufficiently demonstrated.
The FDA is expected to make its approval decision about the drug, which Novartis proposes to call Reasanz, by May 17, 2014.
Read the Bloomberg story