CC - Rhythm receives Breakthrough Therapy and Orphan Drug Designations for setmelanotide for genetic obesity disorders –
Rhythm announced this morning that it has received Breakthrough Therapy and Orphan Drug Designations from the FDA for its melanocortin-4 receptor (MC4R) agonist setmelanotide. Rhythm is developing setmelanotide for two genetic obesity disorders; the Breakthrough Therapy Designation applies to POMC deficiency obesity and the Orphan Drug Designation applies to Prader-Willi syndrome. The Breakthrough Therapy Designation will allow expedited development and review of setmelanotide. The Orphan Drug Designation entitles Rhythm to benefits including grants to fund clinical trials and several years of market exclusivity. Setmelanotide is currently in phase 2 for both indications. See our coverage of Rhythm’s latest financing round for more on this exciting company.
-- by Emily Regier and Kelly Close