Following the negative opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding Novartis’ serelaxin (RLX030), the company has announced it will submit a revised filing package for the drug. Novartis said it will request re-examination for conditional marketing approval for RLX030 in the European Union (EU).
Novartis Pharmaceuticals Division Head David Epstein said, “With the results from RELAX-AHF showing significant mortality benefits with RLX030 in patients with AHF [acute heart failure] and recognizing that there had been no treatment breakthroughs in this area for 20 years, Novartis took a decision to file for regulatory approval.”
RLX030 is a relaxin receptor agonist, a form of naturally occurring hormone in humans. It is at present the only existing drug to demonstrate a reduction in mortality in patients with AHF. Major study data shows the drug is well-tolerated in general. Patients who received RLX030 in the trial had a 37% reduction in mortality at six months after an acute heart failure episode, compared with those who received standard AHF treatment. RLX030 also relieved symptoms and reduced the rate of heart failure deterioration.
AHF is a potentially life threatening condition wherein the heart is unable to pump adequate blood around the body. Over 15 million people are affected by heart failure worldwide. Patients with history of repeated AHF episodes are often at most risk. AHF is estimated to cause more deaths than some advanced cancers such as breast cancer or bowel cancer.
The drug was studied in Phase II of the RELAX-AHF trial. It was granted Breakthrough Therapy designation status by the FDA last June in 2013. Novartis’ filing for regulatory approval is currently under review by the FDA.
“It has become apparent through the review process and in accordance with advice we've received that the current evidence package may be more compatible with an application for conditional approval in the EU. We look forward to providing a revised package for review to the CHMP shortly,” Epstein said. CHMP procedures dictate that a revised opinion could be granted in the second quarter of 2014.