Posted by Michael Wonder on 02 Jul 2020
Rhythm Pharmaceuticals announces submission of marketing authorization application to the European Medicines Agency for setmelanotide in POMC and LEPR deficiency obesities
1 July 2020 - Company also announces positive data from eight supplemental patients, including four paediatric patients, enrolled in pivotal Phase 3 clinical trials; all achieved primary endpoint of 10 percent weight loss.
Rhythm Pharmaceuticals today announced that it has submitted its marketing authorisation application to the EMA for setmelanotide, the company’s melanocortin-4 receptor agonist, for the treatment of pro-opiomelanocortin deficiency obesity and leptin receptor deficiency obesity.
The company has been granted accelerated assessment of the MAA, which potentially shortens review time by the Committee for Medicinal Products for Human Use.
