No EU license yet for serelaxin for treatment of acute heart failure
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 license to be granted in the EU.
RLX030 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. It has multiple effects including relaxing the blood vessels and reducing fluid buildup. Some evidence also suggests it can reduce damage to heart and vital organs, which may be of particular importance when considering the cascade of damage that occurs during an AHF episode.
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.