The Committee for Medicinal Products for Human Use (CHMP) recommended that serelaxin not be approved as a treatment to relieve symptoms in patients with acute heart failure. The European committee’s decision could influence an FDA panel that will review the drug’s application in February.
Serelaxin is a vasoactive peptide hormone that helps to relax the blood vessels and reduce fluid buildup. In the international placebo-controlled randomized RELAX-AHF trial, serelaxin was found to provide dyspnea relief in patients with acute heart failure who had been admitted to a hospital but treatment had no effect on hospital readmission.
In its opinion, CHMP highlighted results that showed serelaxin failed to provide short-term relief but that it did show benefits over five days. The committee questioned the clinical relevance of that benefit and called for further studies.
In a release, Novaris said it planned to submit a revised filing with new analyses. The company has a 15-day window after notification to request a re-examination of the CHMP’s decision.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee is scheduled to discuss serelaxin at its Feb. 13 meeting.