Rhythm Pharmaceuticals' IMCIVREE Receives 'Transformative' FDA Approval for Acquired Hypothalamic Obesity

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On March 19, 2026, the FDA approved an expanded indication for IMCIVREE (setmelanotide) as the first and only therapy for acquired hypothalamic obesity in adults and pediatric patients aged 4 years and older.2

Acquired hypothalamic obesity is a rare disease caused by hypothalamic injury or dysfunction, leading to accelerated weight gain.2

Approval based on Phase 3 TRANSCEND trial results showing -18.4% placebo-adjusted BMI reduction in 142 patients.2

David Meeker, CEO, described the approval as a 'transformative milestone' addressing the underlying biology of the disease.2

Rhythm hosted a conference call on March 19, 2026, at 7:
00 p.m. ET to discuss the approval.2

Sources:

2. https://ir.rhythmtx.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-fda-approval-imcivreer-1