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News|Articles|May 20, 2014
FDA Issues Complete Response Letter for Novartis' RLX030
Author(s)Pharmaceutical Technology Editors
FDA issues complete response letter for Novartis' RLX030 for acute heart failure.
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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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