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Rhythm Pharma Receives Positive CHMP Opinion For Setmelanotide - Quick Facts

Biopharmaceutical company Rhythm Pharmaceuticals, Inc. (RYTM) announced Friday 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 based its positive opinion on the results from two pivotal trials in which setmelanotide achieved statistically significant and clinically meaningful weight loss and reduction in hunger in patients with POMC, including PCSK1, and LEPR deficiency obesity.

Consistent with prior clinical experience, setmelanotide was generally well tolerated in both trials.

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.

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