FDA Reviewers Advise Against Novartis' Reasanz Approval

FDA reviewers have not recommended the approval of Novartis’ acute heart failure drug Reasanz. Despite the negative opinion, Novartis is still going to push for approval for its drug.

Reasanz (serelaxin injection) is a recombinant form of the naturally occurring human relaxin-2 peptide hormone, indicated for the treatment of acute heart failure (AHF). The drug represents a new pharmacologic approach to the treatment of AHF. Results from the RELAX-AHF clinical trial show that serelaxin reduced risk of cardiovascular and all-cause mortality combined with a favorable safety profile. The drug won Breakthrough Therapy designation last year from the FDA, but was rejected for approval in the EU earlier this year.

The recommendation against the drug’s approval comes ahead of an upcoming discussion by the FDA’s Cardiovascular and Renal Drugs Advisory Committee of the biologics license application (BLA) for serelaxin injection. According to the FDA reviewers, collected data supporting the application is inappropriate and insufficient to show that the symptoms of AHF were improved by reducing the rate of worsening heart failure. The reviewers suggested that Novartis conduct an additional study to prove efficacy of the drug.

The company responded that its trial’s endpoints are appropriate and demonstrate sufficient efficacy. “As described in our original briefing document, the primary endpoint that was achieved in the RELAX-AHF trial was the visual analog scale area under the curve during the first five days (VAS AUC)… Taken together, these additional supportive analyses demonstrate that achievement of success on the VAS AUC primary endpoint in the RELAX-AHF trial did not depend on the assignment of an arbitrary numerical value to patients with an unfavorable clinical course,” Novartis stated in its briefing document to the FDA advisory committee.

The reviewers did not raise any significant safety concerns over Reasanz. The committee’s review for the drug’s biologics licensing application will help FDA to decide whether or not to approve Reasanz.