FDA does not approve serelaxin for treatment of acute HF

Novartis announced that it received a Complete Response Letter from the FDA indicating that the agency will not approve a Biologics License Application for serelaxin for the improvement of acute HF symptoms via reduction of the rate of worsening of HF.

The FDA stated that more evidence of the efficacy of serelaxin is required, according to a press release issued by Novartis.

The decision comes after the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously (0-11) against recommending approval of serelaxin in March, saying that the drug showed promise for improvement of worsening of HF and might even favorably impact mortality, but that the data from the phase 3 RELAX-AHF trial, which had primary endpoints related to dyspnea, were not convincing.

“We continue to believe [serelaxin] has the potential to be an important treatment for [acute] HF and have been encouraged by feedback from FDA advisory committee members noting that the data are intriguing,” Tim Wright, MD, global head of development for Novartis, said in the press release. “In accordance with the FDA’s advice, we will continue to expedite our clinical trial program to build the supporting body of evidence.”

The ongoing trial program includes RELAX-AHF-2, which will enroll more than 6,300 patients, according to the press release.