(Adds company comment)
By Toni Clarke
March 27 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
The panel's vote was unanimous. 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.
The trial did not prove the drug significantly improved
shortness of breath either, they said, though the failure may
have had more to do with the design of the trial than the drug
Tim Wright, global head of development at Novartis, said in
a statement that the panel discussion "provided important
information that we will address with the FDA as it completes
"In the meantime, we'll continue to drive our robust
clinical trial program and build upon the already established
body of evidence," he added.
The FDA generally requires evidence from two independent
trials to show an improvement in symptoms. This week reviewers
for the FDA recommended the drug not be approved, saying the
data did not provide "persuasive evidence" of an effect on
shortness of breath, or dyspnea.
Neither did data support Novartis's claim that the drug
reduced the rate of worsening heart failure, the said.
The panel's recommendation echoed that of European
regulators who also ruled against the drug. Novartis has
requested that serelaxin be given conditional approval pending
the results of a second trial designed to show its impact on
Initial data shows the drug reduced deaths by 37 percent
compared with patients in the control group after six months of
treatment. The company hopes to confirm that in an additional
About five million people in the United States are living
with chronic heart failure, a progressive weakening of the
heart, according to Novartis. About one million are hospitalized
with episodes of acute heart failure, and about 22 percent of
patients who are hospitalized die within a year.
If approved, the drug is expected to generate sales of $713
million by 2018 according to the average estimate of five
analysts polled by Thomson Reuters.
The FDA is scheduled to make its decision on the drug, which
would be called Reasanz if approved, by May 17.
(Reporting by Toni Clarke in Washington; Editing by Steve
Orlofsky and James Dalgleish)