Posted by Michael Wonder on 07 Nov 2025
Rhythm Pharmaceuticals announces FDA extension of review period for Imcivree (setmelanotide) for patients with acquired hypothalamic obesity
7 November 2025 - Rhythm Pharmaceuticals today announced that the US FDA has extended by three months the review period for the supplemental new drug application for Imcivree (setmelanotide) for the treatment of acquired hypothalamic obesity.
On 6 November 2025, the FDA notified the Company that the PDUFA goal date has been extended from 20 December 2025 to 20 March 2026.
