Rhythm Pharmaceuticals Inc. Announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for IMCIVREE® (setmelanotide) to treat patients with acquired hypothalamic obesity (HO). The approval, announced March 19, 2026, makes IMCIVREE the first and only FDA-approved therapy for this rare disease, characterized by accelerated and sustained weight gain resulting from injury to, or dysfunction of, the hypothalamus.
The expanded indication covers both adults and pediatric patients aged four years and older with acquired HO. According to Rhythm Pharmaceuticals, the approval is based on data from a Phase 3 clinical trial, TRANSCEND, which demonstrated a placebo-adjusted Body Mass Index (BMI) reduction of 18.4% in patients treated with setmelanotide (N=142).
“With this label expansion, IMCIVREE is indicated to reduce excess body weight and maintain reduction long term in adults and pediatric patients aged 4 years and older with acquired HO,” Rhythm Pharmaceuticals stated in a press release.
David Meeker, a spokesperson for Rhythm Pharmaceuticals, was quoted in the press release, but the specific quote was not immediately available. The company plans to host a conference call today, March 19, 2026, at 7:00 p.m. ET to discuss the approval.
Acquired hypothalamic obesity is a rare condition caused by damage or malfunction of the hypothalamus, a region of the brain that regulates appetite and energy expenditure. Rhythm Pharmaceuticals provides a contact for reporting suspected adverse reactions to setmelanotide: +1 (833) 789-6337.
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