Complete Response Letter Issued for Cardiac Drug
Novartis announced that it has received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for RLX030 (serelaxin) for the treatment of acute heart failure (AHF).
RLX030, a relaxin receptor agonist, is a recombinant form of the human hormone relaxin-2 which occurs naturally in both men and women. In women, levels of relaxin-2 rise to support important physiological changes during pregnancy. Serelaxin acts by relaxing the blood vessels, leading to reduced stress on the heart and kidneys in both men and women.
The BLA submission was based on the results from multiple clinical trials, including the Phase 3 RELAX-AHF study which found that RLX030 reduced all-cause mortality compared to placebo when given to AHF patients upon admission to the hospital in the form of an intravenous infusion for up to 48 hours in addition to loop diuretics and other medicines. The FDA has requested addition evidence of the efficacy of RLX030 in treating AHF and Novartis plans to resubmit the New Drug Application (NDA) with additional data from the ongoing RELAX-AHF-2 clinical trial.
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