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  • Rhythm Pharmaceuticals receives positive CHMP opin...

Rhythm Pharmaceuticals receives positive CHMP opinion for setmelanotide for treatment of obesity and control of hunger associated with POMC, PCSK1 and LEPR deficiency.

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Published:25th May 2021
Rhythm Pharmaceuticals, Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorization for setmelanotide for the treatment of obesity and the control of hunger associated with confirmed loss-of-function biallelic proopiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above.

The CHMP opinion on setmelanotide, which has the PRIority MEdicines (PRIME) designation, will now be reviewed by the European Commission. A final decision on the marketing authorization application for setmelanotide is anticipated in July 2021. If approved by the European Commission, setmelanotide would be the first treatment in the EU indicated for these rare genetic diseases of obesity and would be commercialized under the brand name Imcivree.

Condition: Pro-opiomelanocortin (POMC) Deficiency Obesity
Type: drug

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