FDA panel votes against Novartis drug for acute heart failure

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FDA panel votes against Novartis drug for acute heart failure

A drug made by Novartis AG to treat acute heart failure should not be approved because there is insufficient evidence it improves symptoms, a panel of advisers to the U.S. Food and Drug Administration concluded on Thursday. The FDA is not obliged to follow the advice of its advisory panels but typically does so. Novartis filed for approval of the drug, serelaxin, based on a single study that showed that when given alongside standard treatment it alleviated shortness of breath by slowing the rate of worsening heart failure following hospitalization. Panelists said that while the drug may have reduced worsening heart failure, additional study would be needed to determine the magnitude of the effect.

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