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The Food and Drug Administration has decided that more evidence of serelaxin’s efficacy as a treatment for acute heart failure is needed before the drug can be approved in the United States, Novartis Pharmaceuticals announced May 16.
Serelaxin is a recombinant form of human relaxin-2 hormone that is administered in an intravenous infusion over 48 hours. For approval, the company submitted data from the phase III RELAX-AHF study, an international, randomized, placebo-controlled, double-blind study of about 1,100 patients with acute heart failure. At a meeting in March, the FDA’s Cardiovascular and Renal Drugs Advisory Committee agreed there was evidence that serelaxin had a positive effect on worsening heart failure in the study and that the data were promising, but unanimously voted against recommending approval, citing the need for more studies.
"In accordance with the FDA’s advice we will continue to expedite our clinical trial program to build the supporting body of evidence," Tim Wright, global head of development of the company, said in a statement issued by the company. He added that the company was encouraged by the FDA panel’s feedback.
The company is collecting more data on the drug in acute heart failure, which includes the RELAX-AHF-2 study, which will enroll more than 6,300 patients, according to the statement.
The FDA informs companies about nonapproval decisions in complete response letters, which include advice about what would be needed before the drug can be approved. The FDA does not announce these decisions, but companies often announce when these decisions are made.