RYTM - Rhythm Pharmaceuticals gets positive CHMP opinion for obesity treatment setmelanotide

Rhythm Pharmaceuticals (RYTM) announces that the EMA's 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)).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, the company said.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.

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Rhythm Pharmaceuticals gets positive CHMP opinion for obesity treatment setmelanotide