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Rhythm Pharmaceuticals Announces IMCIVREE® (setmelanotide) Receives <a href="https://healthylife7.com/eli-lilly-stock-falls-while-retatrutide-lawsuits-expand/” title=”Eli Lilly Stock Falls While Retatrutide Lawsuits Expand”>Expanded Marketing Authorization in the United Kingdom for Treatment of Obesity and Control of Hunger in Patients with Acquired Hypothalamic Obesity due to Hypothalamic Injury or Impairment
Rhythm Pharmaceuticals, Inc.
Tue, August 11, 2026 at 5:30 PM GMT+5:30
11 min read
- RYTM
+3.52%
— MHRA grants authorization for patients 4 years of age and above with acquired hypothalamic obesity due to hypothalamic injury or impairment —
BOSTON, Aug. 11, 2026 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has expanded the marketing authorization for IMCIVREE® (setmelanotide) to include the treatment of obesity and control of hunger in adults and children 4 years of age and older with acquired hypothalamic obesity (HO) due to hypothalamic injury or impairment. The MHRA this week also granted IMCIVREE orphan drug designation for acquired HO.
“This authorization marks an important milestone for patients in the UK living with acquired HO,” said David Meeker, M.D., Chairman, President and Chief Executive Officer of Rhythm Pharmaceuticals. “Patients with acquired HO often experience persistent hunger and rapid, severe weight gain that can affect nearly every aspect of their daily life. With the MHRA’s expanded authorization of IMCIVREE, healthcare providers now have an approved treatment option for eligible patients that addresses the underlying biology of this disease.”
IMCIVREE initially received marketing authorization in the UK in 2021 for the treatment of obesity and control of hunger in patients with POMC, PCSK1 or LEPR deficiency and in 2022 for patients with Bardet-Biedl syndrome (BBS). In 2024, the MHRA expanded the authorization to include children as young as 2 years old
“Acquired hypothalamic obesity is a complex condition that can have profound effects on the quality of life and long-term health of children and adults with brain tumours affecting the hypothalamus,” said Prof. Sadaf Farooqi, M.D., Ph.D, University of Cambridge. “The TRANSCEND study showed substantial reductions in BMI in adults and children, demonstrating the effectiveness of MC4R pathway-targeted therapy in people with this condition. These results provide strong evidence for a targeted treatment approach in a condition for which there were previously no approved therapies in the UK.”
The MHRA approval is based on results from the Phase 2 trial and the Phase 3 TRANSCEND trial of setmelanotide in acquired HO. The global, 120-patient trial met its primary endpoint, with a statistically significant -19.8% placebo-adjusted reduction in body mass index (BMI). For the primary endpoint of mean BMI change from baseline, study participants on setmelanotide therapy (n=81) achieved a -16.5% reduction compared with a +3.3% increase among patients on placebo (n=39) at 52 weeks (p<0.0001). Adult patients (age 18 and older; n=49) achieved a -19.2% placebo-adjusted BMI reduction at 52 weeks, and pediatric patients (younger than age 18; n=71) achieved a -20.2% placebo-adjusted BMI reduction at 52 weeks. Patients receiving setmelanotide also experienced reductions in hunger. Setmelanotide was generally well tolerated in the TRANSCEND study. The most common treatment-emergent adverse events (affecting >20% of participants) were nausea, vomiting, diarrhea, injection site reaction, skin hyperpigmentation and headache.
