NEW YORK – Health Canada has approved Boston-based Rhythm Pharmaceuticals' genetically targeted weight management treatment Imcivree (setmelanotide), the biopharmaceutical company said Monday.
Imcivree, a therapy delivered via subcutaneous injection, is designed for adult and pediatric patients at least 6 years of age with obesity due to the genetic disorder Bardet-Biedl syndrome (BBS) or genetically confirmed biallelic pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency.
Imcivree is the first approved therapy in Canada to target variations in the MC4R gene that cause severe early-onset obesity for patients with these conditions. Such mutations in the MC4R gene lead to dysregulation in a system in the hypothalamus that regulates hunger and satiety, which Imcivree activates. Imcivree also increases resting metabolism.
Health Canada approved Imcivree based on results from Phase III trials in patients with obesity due to BBS and POMC, PCSK1, and LEPR deficiencies, in which patients achieved statistically significant weight loss after 52 weeks on Imcivree. The most common adverse reactions were skin hyperpigmentation, injection site reactions, and nausea.
Rhythm Pharmaceuticals said it plans to make the drug commercially available in Canada in the coming months.
"This approval will bring much-needed relief to patients and their families who need a therapeutic option that addresses an underlying cause of obesity associated with these rare MC4R pathway diseases," Jill Hamilton, a pediatric endocrinologist at The Hospital for Sick Children, said in a statement.
The drug is already approved by the US Food and Drug Administration and authorized by the European Commission and the UK's Medicines and Healthcare Products Regulatory Agency.