Rhythm Pharmaceuticals Gets Positive CHMP Opinion for Imcivree

By Chris Wack

Rhythm Pharmaceuticals Inc. said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending to expand the current marketing authorization for Imcivree.

The new recommendation for Imcivree, or setmelanotide, includes the treatment of obesity and control of hunger in adult and pediatric patients six years of age and older with genetically confirmed Bardet-Biedl syndrome.

The CHMP opinion would now be reviewed by the European Commission, which has the authority to grant and expand marketing authorizations for medicinal products in the European Union.

A final decision on the application to expand the marketing authorization for Imcivree is anticipated in the fourth quarter of 2022.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

July 22, 2022 09:18 ET (13:18 GMT)

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