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Rhythm Pharmaceuticals Receives Positive CHMP Opinion for ▼¹ IMCIVREE® (setmelanotide) for the Treatment of Obesity and Control of Hunger in Patients with Bardet-Biedl Syndrome
-- European Commission decision anticipated in fourth quarter of 2022 -- BOSTON, July 22, 2022 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- European Commission decision anticipated in fourth quarter of 2022 -- BOSTON, July 22, 2022 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending to expand the current marketing authorization for IMCIVREE® (setmelanotide) 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 (BBS). “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,” said David Meeker, M.D., Chairman, President and Chief Executive Officer of Rhythm. “Approximately 1,500 patients have already been diagnosed with BBS and are now being cared for at academic settings in Europe. We look forward to continuing our work with Health Technology Assessment bodies and payers across Europe to achieve access to setmelanotide for patients with BBS.” Philip Beales, M.D., University College London, Institute of Child Health, said, “Patients living with BBS are looking for a transformational treatment that can significantly reduce hunger and body weight. If approved, setmelanotide could change the treatment paradigm for these patients and their families, providing them an option that not only has the potential to address the physical aspects of the disease, but also its negative effects on overall health, well-being and quality of life.” The CHMP opinion will now be reviewed by the European Commission (EC), 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. About Rhythm PharmaceuticalsRhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with hyperphagia ...