Rhythm Pharmaceuticals Says Imcivree Receives Expanded Marketing Authorization in UK

MT Newswires Live12-03

Rhythm Pharmaceuticals (RYTM) said Tuesday that the UK's Medicines & Healthcare products Regulatory Agency has expanded the marketing authorization for Imcivree to include the treatment of obesity and control of hunger associated with Bardet-Biedl syndrome or biallelic pro-opiomelanocortin in patients aged two years and up.

Imcivree initially received marketing authorization for treating obesity and controlling hunger in patients aged six years and older in these indications in 2022, the company said.

With this expanded authorization, the company said Imcivree will be available through the Medicines for Children program by the end of this year.

A supplemental new drug application for Imcivree for patients as young as two years old is currently under priority review with the US Food and Drug Administration, with a decision expected on Dec. 26.

A late-stage clinical trial found that the drug may reduce hyperphagia, weight and body mass index in children, the company said.

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