Novartis Heart Drug Doesn’t Prove Benefit, FDA Staff Says
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Novartis AG’s experimental heart failure medication shouldn’t be approved for sale, U.S. regulators said, potentially dealing a blow to the company’s plan to build a portfolio of cardiac therapies around the drug.
“There is insufficient evidence to support” Novartis’s claim the drug, serelaxin, helps prevent worsening of the disease that causes the heart to malfunction, Food and Drug Administration staff said today in a document posted online. The FDA on March 27 will convene advisers to consider serelaxin.