Rhythm Pharma's Imcivree Gets European Approval For Obesity, Control of Hunger Associated With Genetic Mutations - Rhythm Pharmaceuticals (NASDAQ:RYTM)

The European Commission (EC) has approved Rhythm Pharmaceuticals Inc's RYTM Imcivree (setmelanotide) for obesity and the control of hunger.
The approval covers obesity 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) in adults and children six years and above.
Obesity due to POMC, PCSK1, or LEPR deficiency is an ultra-rare disease caused by variants in POMC, PCSK1, or LEPR genes that impair the MC4R pathway regulates hunger, energy expenditure, and consequently body weight.
The approval is based on two Phase 3 trials, showing that 80% of patients with obesity due to POMC or PCSK1 deficiency achieved greater than 10% body weight loss.
45.5% of patients with obesity due to LEPR deficiency achieved greater than 10% body weight loss after one year of treatment.
Additionally, in both studies, a significant decrease in body mass index was demonstrated across patients.
Price Action: RYTM shares are up 2% at $19.78 during the market session on the last check Friday.
Related content: Benzinga's Full FDA Calendar.