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

GSK Fined in China Bribery Scandal
September 19, 2014
Guideline Delineates How to Implement GS1 Standards to Support DSCSA
September 19, 2014
Pandemic Vaccine Facility Dedicated in Texas
September 19, 2014
GPhA Supports Restricted Access Bill
September 18, 2014
Baxter Initiates Voluntary Recall of Potassium Chloride Injection
September 17, 2014
Author Guidelines

Click here