Novartis said in a statement the Food and Drug
Administration (FDA) had asked for further evidence to determine the
efficacy of serelaxin, also known as RLX030.
The decision follows a unanimous recommendation from a panel of
advisers in March against approving the drug.
Serelaxin is one of several potential "blockbuster" drugs the
Basel-based pharmaceutical company is looking to as it bets on
cancer, heart and respiratory treatments to fill the gaps left by
patent expiries on drugs such as Diovan, which lost U.S. patent
rights and faces generic competition.
Tim Wright, global head of development at Novartis, said Novartis
still believed serelaxin had the potential to become "an important
treatment" for acute heart failure.
Novartis is continuing with its clinical trial programme in order to
build up a further body of evidence and plans to enrol over 6,300
patients in a second late-stage trial, the company said.
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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.
(Reporting by Caroline Copley; Editing by Mark Potter)
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