U.K. Approves Rhythm Pharma's Imcivree For Treatment Of Obesity And Control Of Hunger

Rhythm Pharmaceuticals Inc. (RYTM) said that the Great Britain's Medicines & Healthcare Products Regulatory Agency or MHRA has granted marketing authorisation to Imcivree or setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 or PCSK1, deficiency or biallelic leptin receptor or LEPR deficiency in adults and children 6 years of age and above.

It is the first-ever authorised treatment option in Great Britain (England, Scotland and Wales) for these rare genetic diseases of obesity, the company said.

The National Institute for Health and Care Excellence or NICE is scheduled to review the dossier for Imcivree in December 2021. Guidance for coverage of Imcivree under the United Kingdom's National Health Service (NHS) is anticipated in the second quarter of 2022.

The company noted that the MHRA authorisation of Imcivree is based on results from the largest studies conducted to date in obesity due to POMC, PCSK1 or LEPR deficiency.

In two Phase 3 clinical trials, 8 of 10 patients with obesity due to POMC or PCSK1 deficiency achieved greater than 10 percent body weight loss after one year of treatment with IMCIVREE and 5 of 11 patients with obesity due to LEPR deficiency achieved greater than 10 percent body weight loss after one year of treatment with IMCIVREE.

Additionally, in both studies, significant decreases in body mass index (BMI) were demonstrated across patients who were 6 to 17 years old at baseline.

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