FDA Accepts Rhythm Pharma' SNDA For Setmelanotide To Treat Acquired Hypothalamic Obesity

(RTTNews) - Rhythm Pharmaceuticals, Inc. (RYTM) announced that the U.S. Food and Drug Administration has accepted for filing the company's supplemental New Drug Application or sNDA for setmelanotide seeking approval for the treatment of conditions associated with acquired hypothalamic obesity.

The FDA has granted Priority Review of the sNDA and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2025.

Additionally, the European Medicines Agency (EMA) has confirmed validation of the Type II variation submission to the Marketing Authorization Application (MAA) for setmelanotide for the same indication. The application review began on August 16, 2025, by the Committee for Medicinal Products for Human Use (CHMP), which will issue an opinion to the European Commission (EC) regarding potential approval.

Setmelanotide is a melanocortin-4 receptor (MC4R) agonist, previously approved as IMCIVREE by the FDA, the EMA, and UK's Medicines & Healthcare Products Regulatory Agency (MHRA) for obesity due to Bardet-Biedl syndrome and POMC, PCSK1 or LEPR deficiencies.

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