Novartis Provides Update on EU Marketing Authorization Application for RLX030 in Acute Heart Failure

Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion for the use of RLX030 (serelaxin) in the treatment of acute heart failure (AHF) indicating that further evidence is required for a licence to be granted in the EU. This follows the company's request for re-examination after a previous negative opinion was issued in January. Novartis aims to resubmit for approval as soon as additional data is available from the ongoing global trial program, including the 6300 patient RELAX-AHF-2 study, one of the largest and most robust programs undertaken by a company for an AHF drug.

"We are disappointed that patients in Europe will not have access to RLX030 in 2014 but we believe in the value that RLX030 can bring to patients and are committed to extending the current evidence base to confirm this," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "Twenty million people across the world face poor quality of life and high risk of death from heart failure and it remains our mission to change the course of this disease with our research and development efforts."