insufficient evidence that it improves symptoms, Novartis said.
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 from the Basel (Swiss)-based pharmaceutical company.
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 program in order to build up a further body of evidence and plans to enroll over 6,300 patients in a second late-stage trial, the company said.
Approximately 23 million people are diagnosed with Heart Failure across the globe.