Novartis Fails to Win U.S. Approval for Serelaxin Heart Drug
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Novartis AG’s heart-failure medication failed to win U.S. approval, setting back the company’s plan to build a portfolio of cardiac therapies around the drug.
The Food and Drug Administration asked for more information about the medicine called serelaxin, according to a statement from the company. A panel of advisers to the FDA unanimously recommended against approval March 27. They agreed with FDA staff members who said in a March 25 report they found insufficient evidence that serelaxin will benefit patients. Novartis said it will expedite a program of clinical trials to gather more evidence.