
FDA Issues Complete Response Letter for Novartis' RLX030
FDA issues complete response letter for Novartis' RLX030 for acute heart failure.
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.
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