Rhythm Pharmaceuticals Announces FDA Extension of Review Period for IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity

Core Viewpoint - Rhythm Pharmaceuticals has announced an extension of the FDA review period for the supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) by three months, moving the PDUFA goal date from December 20, 2025, to March 20, 2026 [1][2] Company Overview - Rhythm Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases, with its lead product IMCIVREE® (setmelanotide) aimed at treating acquired hypothalamic obesity [1][6] - Setmelanotide is already approved by the FDA for reducing excess body weight in patients aged 2 years and older with specific genetic obesity syndromes [6][7] Regulatory Update - The FDA requested additional sensitivity analyses of clinical efficacy data from Rhythm's Phase 3 pivotal trial, which has been classified as a 'major amendment' allowing for an extended review period [2] - No new safety or manufacturing data was requested by the FDA, indicating that the focus remains on the efficacy data [2] Management Commentary - David Meeker, CEO of Rhythm, expressed confidence in the product profile of setmelanotide and the ongoing collaboration with the FDA to bring the treatment to patients who currently lack approved options [3] Conference Call Information - Rhythm Pharmaceuticals will hold a conference call and webcast to discuss the update at 8:00 a.m. ET, with registration recommended ten minutes prior to the start [4][5]