FDA Rejects Novartis’ Heart Failure Drug--Again

Novartis' experimental heart failure drug, Serelaxin, was yet again rejected by the U.S. Food and Drug Administration after undergoing another trial to prove its effectiveness and ability to improve symptoms in patients.

Back in March, Serelaxin failed to gain support from another FDA panel that unanimously voted the drug should not be cleared for sale. The 11-member advisory panel said there was not sufficient evidence provided that the drug will benefit patients. As a result, the FDA asked Novartis to expand their trial to further prove the Serelaxin's efficacy.

But after nearly two months the FDA panel has not wavered. Novartis announced on Thursday that the FDA issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for Serelaxin for the treatment of acute heart failure (AHF). In other words, again, the FDA needs more evidence on the drug's effectiveness before it's granted a license to be sold in the United States.

"We continue to believe RLX030 [Serelaxin] has the potential to be an important treatment for AHF and have been encouraged by feedback from FDA advisory committee members noting the data are intriguing," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals, in a news release. "In accordance with the FDA's advice we will continue to expedite our clinical trial program to build the supporting body of evidence."

In response to the FDA's rejection, Novartis plans to enroll over 6,300 patients in a second late-stage trial to prove Serelaxin's efficacy. But the United States is not alone in rejecting the new heart failure drug. Serelaxin failed to win approval from European Union regulators back in January, who also questioned the drug's effectiveness. It seems as if the regulators want to be surefooted about Serelaxin before millions of people begin purchasing it, as it's expected (after it's approved) to generate over $500 million in 2018.

Nonetheless, the regulators simply want more evidence. In the U.S. about 5.1 million people have heart failure and half of these people die within five years of diagnosis, according to the Centers for Disease Control and Prevention. Medical costs associated with heart failure are in excess of $32 billion each year. Serelaxin is expected to be costly, but it should save patients money in the long run.