FDA Issues Complete Response Letter for Novartis' RLX030 - - BioPharm International

ADVERTISEMENT

FDA Issues Complete Response Letter for Novartis' RLX030



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

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

New Tax Rules May Deter Future Pharma M&A
October 1, 2014
NIH Seeks to Improve Vaccine Response with New Adjuvants
September 30, 2014
New Report Details Players and Pipelines in the Biosimilar Space
September 30, 2014
Baxter International Plans to Open R&D Center for Baxalta
September 30, 2014
FDA Releases First-Ever Purple Book for Biosimilar Characterization
September 26, 2014
Author Guidelines

Click here