Novartis AG's heart failure drug, serelaxin, failed to seek support from a United States Food and Drug Administration panel. Due to lack of evidence of the drug to benefit heart patients, the FDA panelists voted unanimously against the drug. However, a final decision is still awaited till May 17.

Serelaxin is aimed at treating acute heart failure, but the FDA panelists remained skeptical on the magnitude of the drug's effect. There is no doubt that some positives came out during the trial period, but they were not good enough to convince the panelists to give a go ahead to become a standard treatment for acute heart failure. The drug also failed to show any improvement for those with shortness of breath.

At least two independent trials are required by the FDA to test a drug's effectiveness and the evidence from serelaxin's two trials failed to provide enough evidence to the panelists to bid their vote for the drug.

The drug also failed to get the approval from European regulators as they voted against it in January this year. The FDA panelists said that Novartis failed to present the drug's features in the trial phase. The magnitude of the drug's most quality feature is the base of the process of getting a drug approved by the FDA.

In the case of serelaxin, the trials showed that it does have the efficacy of reducing death from heart failure, but the drug's application on improving labored breathing was focused by Novartis, which it was found incapable of doing.

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