Novartis to Request Re-Examination of Serelaxin in Acute Heart Failure for Conditional Marketing Authorisation in EU

Novartis will shortly submit a revised filing package, including new data analyses, for re-examination for conditional approval of RLX030 (serelaxin) for acute heart failure by the Committee for Medicinal Products for Human Use (CHMP) following a negative opinion issued 24 January 2014. In accordance with CHMP process a revised opinion could be granted in Q2 2014.

The file for regulatory approval is continuing review by FDA in the US where RLX030 was granted Breakthrough Therapy designation status in June 2013[2]. Reviews are also underway with health authorities in 16 countries around the world.

"With the results from RELAX-AHF showing significant mortality benefits with RLX030 in patients with AHF and recognizing that there had been no treatment breakthroughs in this area for 20 years, Novartis took a decision to file for regulatory approval," said David Epstein, Division Head of Novartis Pharmaceuticals. "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."

In September 2013 the second phase III study RELAX-AHF-2 started recruitment of the over 6000 patients who are expected to be enrolled. The goal is to replicate the key findings of RELAX-AHF and the study will assess cardiovascular mortality as the primary endpoint. This would be one of the largest and most robust programmes undertaken by a company for an AHF drug.

RLX030, a relaxin receptor agonist[3], is a form of a naturally occurring hormone (human relaxin 2) present in both men and women which rises in women during pregnancy to help the body cope with the additional cardiovascular demands[4,5]. RLX030 is thought to have multiple effects including relaxing the blood vessels, reducing fluid buildup and protecting the heart and vital organs from the cascade of damage that occurs during an AHF episode[3,6–9]. More than 1.5 million AHF episodes happen every year in Europe alone[10,11], with 1 in 5 patients not surviving a year afterwards[12–17].

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