FDA Reviewers Recommend Against Approval of Novartis’ Reasanz

FDA reviewers are recommending against approving a Novartis heart drug, saying the data collected is inappropriate and insufficient to improve the symptoms of acute heart failure by reducing the rate of worsening heart failure. The agency suggests that the company conduct an additional study to demonstrate efficacy.

According to briefing documents released by the FDA on Tuesday, the single Phase III Relax-AHF trial used to support Reasanz’s (serelaxin) approval is insufficient to show efficacy. The staff review raised no significant safety concerns.

Reasanz is a genetically engineered hormone that relaxes blood vessels, creating less demand on the heart.

Despite the FDA reviewers’ conclusion, Novartis is sticking to its guns. In the company’s own briefing document, the sponsor argues that its endpoints are appropriate and show sufficient efficacy leading to “an almost 50 percent reduction of in-hospital [worsening of heart failure].”

The FDA’s Cardiovascular and Renal Drugs Advisory Committee is scheduled to meet Thursday to review a biologics licensing application for Reasanz and recommend whether or not the agency should approve the drug. — Ferdous Al-Faruque

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.