March 27th, 2014

FDA Advisory Panel Recommends Against Approval of Novartis Heart Failure Drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously (11-0) against approval of the biologics license application (BLA) for serelaxin (proposed trade name, Reasanz). The novel drug from Novartis was intended to be used in patients with acute heart failure (HF). The once highly promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was also turned down for approval in Europe earlier this year.

FDA reviewers and committee members expressed no significant concerns over the safety of the drug. But they were troubled by the seemingly impenetrable results of the pivotal RELAX-AHF trial. Throughout the day the Novartis speakers, including HF specialists Milton Packer and RELAX-AHF investigator Barry Greenberg, tried to explain and justify the complex trial, which only met one of its two co-primary endpoints.

But panel members remained skeptical. They found that flaws in trial design made it impossible to accurately assess the effect of the drug. They did not completely reject the surprising finding of a mortality reduction at 180 days in RELAX-AHF, but because it was not a prespecified endpoint they said it needed to be tested in a followup study.

After the vote most of the panelists advised the company to continue development of the drug since it may ultimately help address an important unmet medical need.

Novartis sent the following statement after the panel meeting:

“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 II and III trials with no significant safety concerns,” said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. “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 our robust clinical trial program and build upon the already established body of evidence.”


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