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FDA issues complete response letter for Novartis' RLX030 for acute heart failure.
Novartis reported that FDA has issued a complete response letter (CRL) regarding the biologics license application for RLX030 (serelaxin) for the treatment of acute heart failure (AHF), stating that further evidence on the efficacy of RLX030 is required for a US license to be granted.
The RLX030 submission to the FDA included phase II and III efficacy and safety data from the clinical development program, including the phase III RELAX-AHF study. Novartis is continuing to expand the data supporting the efficacy of RLX030 in acute heart failure with a global clinical program, including the RELAX-AHF-2 trial, which will enroll over 6300 patients.