FDA Rejects Acute Heart Failure Drug Serelaxin

After FDA reviewers advocated for not accepting the acute heart failure drug, an advisory panel voted unanimously to reject serelaxin.

After US Food and Drug Administration (FDA) reviewers recommended not approving Novartis’ acute heart failure (AHF) drug serelaxin, the FDA advisory panel voted unanimously (11-0) to recommend against approval on Thursday.

The FDA panel found flaws in the drug’s trial design, which they believed made it impossible to assess the efficacy of the drug. The study, published in the Lancet, found 19.4% improvement of dyspnea relief in 1,161 patients through day 5 compared to a placebo, though no differences were noted at 24 hours.

The panel noted they did not reject the drug on the basis of the morality reduction finding — mortality was down in the serelaxin group compared to placebo after 180 days – but said that it was not a prespecified endpoint. The FDA panel encouraged more studies and further development of the drug, because ultimately, it will address an important medical need that is currently unmet.

“Recognizing the urgent patient need, today we presented what we believe to be a persuasive picture of the evidence for RLX030 so far — compelling results from our Phase 2 and 3 trials with no significant safety concerns,” Tim Wright, Global Head of Development, Novartis Pharmaceuticals, said in a statement. “The discussion provided important information that we will address with the FDA as it completes its review. In the meantime, we’ll continue to drive out robust clinical trial program and build upon the already established body of evidence.”