CHMP rejects serelaxin again for Heart Failure - Novartis

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion for the use of RLX030 (serelaxin) (tentatively called Reasanz) in the treatment of acute Heart Failure (AHF) indicating that further evidence is required for a license 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 6,300 patient RELAX-AHF-2 study, one of the largest and most robust programs undertaken by a company for an AHF drug. An application to the FDA recently was unsuccessful.