May 16th, 2014

FDA Turns Back Novel Drug for Acute Heart Failure

Novartis said today that the FDA had issued a complete response letter for the biologics license application for RLX030. The drug, also known as serelaxin, is a recombinant form of the naturally occurring human hormone relaxin-2, which has been found to help women adjust to the cardiovascular changes that occur during pregnancy.

The FDA decision was not unexpected since earlier this year its Cardiovascular and Renal Drugs Advisory Committee voted unanimously against approval. The rejection occurred despite the fact that the drug received a ”breakthrough therapy” designation from the FDA last year. Serelaxin was also turned down for approval in Europe earlier this year.

Novartis said it plans to continue development of the drug. “We continue to believe RLX030 has the potential to be an important treatment for AHF and have been encouraged by feedback from FDA advisory committee members noting the data are intriguing,” said a company executive. “In accordance with the FDA’s advice we will continue to expedite our clinical trial program to build the supporting body of evidence.”

The BLA relied heavily on data from the the pivotal phase III RELAX-AHF study. Novartis said it was “continuing to expand the data supporting the efficacy of RLX030 in acute heart failure with an extensive global clinical program, including the RELAX-AHF-2 trial which will enroll over 6,300 patients.”


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