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
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