Posted by Michael Wonder on 02 Jul 2020
Rhythm Pharmaceuticals receives rare paediatric disease designation from U.S. FDA for setmelanotide for treatment of POMC and LEPR deficiency obesities
1 July 2020 - Rhythm Pharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designations for setmelanotide, an investigational melanocortin-4 receptor agonist, for the treatment of pro-opiomelanocortin deficiency obesity and leptin receptor deficiency obesity.
As previously announced, the Company’s new drug application for setmelanotide was accepted for filing with priority review by the FDA and assigned a Prescription Drug User Fee Act goal date of 27 November 2020.
