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Rhythm Pharma's Imcivree Gets European Approval For Obesity, Control of Hunger Associated With Genetic Mutations

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  • The European Commission (EC) has approved Rhythm Pharmaceuticals Inc's (NASDAQ: 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.

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