The U.S. Food and Drug Administration (FDA) has approved Rhythm Pharmaceuticals’ (NASDAQ:RYTM) supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide), a melanocortin-4 receptor (MC4R) agonist, for patients with Bardet-Biedl syndrome (BBS).
The regulatory approval was supported by data readout from pivotal Phase 3 clinical trial, which was the largest and longest interventional clinical trial in BBS, the trial met its primary endpoint and all key secondary endpoints.
