FDA staff review recommends against Novartis heart failure drug

By Toni Clarke WASHINGTON (Reuters) – A drug to treat acute heart failure made by Novartis AG should not be approved because there is insufficient evidence to show it improves symptoms, according to an initial review by the U.S. Food and Drug Administration. The review, posted on the FDA's website on Tuesday, comes two days ahead of a meeting of outside advisors who will make their own recommendation on whether the drug should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does so. Acute heart failure is a medical emergency in which patients become short of breath as the heart struggles to pump blood and fluid around the body.