- Rhythm Pharmaceuticals (NASDAQ:RYTM) announces that the European Commission (EC) has granted marketing authorization to the company's weight management treatment Imcivree (setmelanotide) in the European Union (EU).
- IMCIVREE looks to treat obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above.
- Obesity due to POMC, PCSK1 or LEPR deficiency is an ultra-rare disease that impair the MC4R pathway, which is a pathway in the hypothalamus that is responsible for regulating hunger, energy expenditure and consequently body weight.
- The approval of Imcivree is based on results from two late-stage trials, where 80% of ten patients with obesity due to POMC or PCSK1 deficiency achieved greater than ten percent body weight loss after one year of treatment.
- The company also highlighted that Imcivree was generally well-tolerated in clinical trials.