FDA Issues Complete Response Letter for Novartis' RLX030
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.
Source: Novartis
Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact
April 16th 2025On April 14, 2025, the Trump Administration launched a national security-driven investigation into pharmaceuticals, a move that will likely result in tariffs being placed on pharmaceutical drugs, ingredients, and other components that are imported from outside of the United States.
