FDA issues Complete Response Letter to Novartis for RLX 030 for Heart Failure.
Novartis announced that the FDA has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RLX 030 (serelaxin) for the treatment of Acute Heart Failure (AHF), stating that further evidence on the efficacy of RLX 030 is required for a US license to be granted. The RLX 030 submission to the FDA included phase II and III efficacy and safety data from the clinical development program, including the pivotal phase III RELAX-AHF study. Novartis is continuing to expand the data supporting the efficacy of RLX 030 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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