EMA/CHMP again rejects Novartis' serelaxin for AHF

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has for a second time adopted a negative opinion for the use of Swiss drug major Novartis’ (NOVN: VX) serelaxin (RLX030) in the treatment of acute heart failure (AHF), indicating that further evidence is required for a license to be granted in the European Union.

This follows the company's request for re-examination after a previous negative opinion was issued early this year (The Pharma Letter January 24). Novartis aims to resubmit for approval as soon as additional data is available from the ongoing global trial program, including the 6,300 patient RELAX-AHF-2 study, one of the largest and most robust programs undertaken by a company for an AHF drug.

Also turned down by FDA