WASHINGTON, March 25 A drug to treat acute heart failure made by Novartis AG should not be approved because there is insufficient evidence to show it improves the symptoms of acute heart failure, according to the U.S. Food and Drug Administration.
Its initial report, 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. The drug, serelaxin, is a genetically engineered hormone that relaxes blood vessels and eases the burden on the heart.
"We recommend that serelaxin not be approved at this time because there is insufficient evidence to support the proposed indication to "improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure," the report said. "We did not identify any significant safety concerns precluding approval." (Reporting by Toni Clarke in Washington; Editing by Stephen Powell)