16 June 2022 - Approval based on Phase 3 trial results that demonstrated statistically significant reductions in weight and hunger in patients with Bardet-Biedl syndrome.
Rhythm Pharmaceuticals today announced that the U.S. FDA has approved the Company’s supplemental new drug application for Imcivree (setmelanotide), a melanocortin 4 receptor agonist, for patients with Bardet-Biedl syndrome.