10:35 AM EDT, 06/28/2024 (MT Newswires) -- Rhythm Pharmaceuticals ( RYTM ) said Friday it had received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, recommending an expanded marketing authorization for Imcivree to include children between 2 and 6 years old with neuroendocrine diseases.

The company said it expects a decision from the European Commission, which will now review the committee's recommendation, in H2.

The CHMP recommended that the marketing authorization for Imcivree, or setmelanotide, be expanded to include children 2 years up to under 6 years old with obesity due to Bardet Biedl syndrome or pro-opiomelanocortin, proprotein convertase subtilisin/kexin type 1, or leptin receptor deficiency, the biopharmaceutical company said.

The drug is approved in the EU to treat obesity in adults and children 6 years and older with neuroendocrine diseases, the company added.

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