The FDA followed the lead of its counterpart in Europe by rejecting a bid from Novartis to approve serelaxin as a treatment for acute heart failure. The FDA stated that it needed more proof of the drug’s efficacy.
The FDA granted serelaxin breakthrough therapy designation in June 2013. Novartis proposed it as a symptom reliever for patients with acute heart failure who present at the emergency department. Serelaxin, a vasoactive peptide hormone, was to be infused over a 48-hour period to help relax blood vessels and reduce fluid buildup.
In the international placebo-controlled randomized Relaxin for the Treatment of Acute Heart Failure (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. Earlier this year, the Committee for Medicinal Products for Human Use in Europe determined that 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, though, and did not support serelaxin’s approval. The FDA’s Cardiovascular and Renal Drugs Advisory Committee, in a meeting in March, also voted unanimously against approval of the drug.
Basel-based Novartis said it will continue to its efforts with the ongoing RELAX-AHF-2, which will enroll almost three times as many patients.