Rhythm Pharmaceuticals, Inc. (RYTM), focused on hyperphagia and severe obesity caused by rare melanocortin-4 receptor or MC4R pathway diseases, announced Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion for IMCIVREE (setmelanotide).
CHMP has recommended to expand the current marketing authorization for IMCIVREE to include the treatment of obesity and control of hunger in adult and pediatric patients 6 years of age and older with genetically confirmed Bardet-Biedl syndrome or BBS.
The CHMP opinion will 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 setmelanotide is anticipated in the fourth quarter of 2022.
David Meeker, Chairman, President and Chief Executive Officer of Rhythm, said, “The positive opinion from the CHMP marks another important step toward our goal of delivering the first precision medicine to treat severe, early-onset obesity and hyperphagia in patients living with BBS across Europe. Approximately 1,500 patients have already been diagnosed with BBS and are now being cared for at academic settings in Europe.”
Earlier this week, IMCIVREE was recommended by the National Institute for Health and Care Excellence or NICE for treating obesity and controlling hunger caused by POMC or LEPR Deficiency in people six years of age and over.
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