FDA Unanimously Declines Novartis Heart Failure Drug Today

Due to "insufficient evidence" that Novartis AG's heart failure drug, serelaxin, will benefit patients, a United States Food and Drug Administration panel has unanimously voted against it. A final decision will be made on the drug by May 17.

Serelaxin is intended to treat acute heart failure, but the FDA panelists questioned the magnitude of the drug's effect. The trial period showed some positives, but the panelists weren't completely sold. It also showed no improvement for those with shortness of breath.

The FDA requires two independent trials to test a drug's effectiveness, and the evidence from serelaxin's two trials was not convincing enough for the voters. European regulators also voted against the drug's approval back in January. As a result, Novartis has requested a conditional approval pending serelaxin's results from an additional trial that will examine its impact on mortality.

"I think this was more a failure of trial design than it was of the drug itself," said Stuart Rich, a panel member and professor at the University of Chicago Pritzker School of Medicine in this Bloomberg Businessweek article. "A drug that will reduce morbidity, mortality, length of stay is really needed and hopefully these hypotheses in this trial will be proven out."

The panelists believe that Novartis did not properly present the drug's features in the trial phase. The process of getting a drug approved by the FDA primarily depends on the magnitude of the drug's most quality feature. In this case, serelaxin's strength is reducing death from heart failure, which the trials showed it was capable of doing. But Novartis focused the drug's application on improving labored breathing, which it did not overwhelmingly show.

Novartis is already in the process of reapplying for approval from the European Union after it completes a trial that focuses on the drug's effectiveness to reduce deaths. This study is projected to be complete by the end of 2016. Novartis hopes to utilize serelaxin on heart failure patients who are hospitalized each year, which numbers one million in the United States.

To read more about the FDA's unanimous vote against Novartis' serelaxin, visit this Reuters news article.