Posted by Michael Wonder on 27 Aug 2024
Rhythm Pharmaceuticals announces FDA acceptance for priority review of supplemental new drug application for Imcivree (setmelanotide) in patients as young as 2 years old
26 August 2024 - FDA sets PDUFA goal date of 26 December 2024.
]Rhythm Pharmaceuticals today announced that the US FDA has accepted the company’s supplemental new drug application for Imcivree (setmelanotide), a melanocortin-4 receptor agonist, for the treatment of obesity due to Bardet-Biedl syndrome or pro-opiomelanocortin, including proprotein convertase subtilisin/kexin type 1, or leptin receptor deficiency obesity in children as young as 2 years old.
