On March 26, 2026, Rhythm Pharmaceuticals, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the expansion of the current marketing authorization for IMCIVREE (setmelanotide). This expansion aims to include the treatment of obesity and the control of hunger in adults and children aged 4 years and above with acquired hypothalamic obesity (HO) due to hypothalamic injury or impairment. The CHMP's positive opinion is a significant milestone for Rhythm, as it follows closely after the recent FDA approval of IMCIVREE, validating the quality of the data supporting their filings in acquired HO. David Meeker, M.D., Chairman, President, and CEO of Rhythm, emphasized the importance of this development, stating that acquired HO represents a significant unmet medical need and presents a unique opportunity for the company. 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 from the EC is anticipated in the second quarter of 2026. This development is expected to positively impact Rhythm's market position and growth potential, as it expands the therapeutic indications for IMCIVREE, potentially increasing its patient base and revenue streams.

Press Release distribution

National Press Distribution across U.S. Media. Direct Access to Key Decision Making Editors.