FDA Set Review Date for Imcivree for Rare Form of Obesity

The FDA has accepted Rhythm Pharmaceuticals' supplemental new drug application (sNDA) for Imcivree (setmelanotide), seeking approval to treat patients with 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 Dec. 20, 2025.

Acquired hypothalamic obesity is a rare form of obesity that occurs after a physical injury or structural abnormality of the hypothalamus, a region of the brain responsible for energy balance, autonomic nervous system regulation, circadian rhythm and controlling pituitary hormones. The hypothalamus can be injured during surgery to remove brain tumors or as a result of head trauma, infections, radiation or bleeding in the brain.

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