21 May 2021 - EMA has recommended granting a marketing authorisation in the European Union for Imcivree (setmelanotide) to support weight loss and management in patients from 6 years of age with obesity caused by the following rare genetic disorders: pro-opiomelanocortin deficiency – including proprotein convertase subtilisin/kexin type 1 deficiency – and leptin receptor deficiency in adults and children.
These conditions must be confirmed by genetic testing before a patient can start treatment with Imcivree.