Posted by Michael Wonder on 21 Aug 2025
Rhythm Pharmaceuticals announces FDA acceptance of sNDA for setmelanotide in acquired hypothalamic obesity
20 August 2025 - US FDA accepts sNDA for filing with priority review; sets PDUFA goal date of 20 December 2025.
Rhythm Pharmaceuticals today announced that the US FDA has accepted for filing the company’s supplemental new drug application for setmelanotide seeking approval for the treatment of conditions associated with acquired hypothalamic obesity.
Additionally, the EMA has confirmed validation of the Type II variation submission to the marketing authorisation application for setmelanotide for the same indication. The application review began on 16 August 2025, by CHMP, which will issue an opinion to the European Commission regarding potential approval.
