Rhythm Pharmaceuticals reported a strong start to the U.S. launch of IMCIVREE® for Bardet-Biedl syndrome (BBS) with over 50 prescriptions written in the first six weeks. The EMA's CHMP recommended expanding IMCIVREE's marketing authorization to include the treatment of obesity and control of hunger in patients with genetically confirmed BBS. Positive interim results from the Phase 2 trial in hypothalamic obesity were announced, with plans to initiate a Phase 3 trial in early 2023.
Received FDA approval for IMCIVREE® (setmelanotide) as the first-ever therapy for patients with Bardet-Biedl syndrome
U.S. launch off to a strong start with more than 50 IMCIVREE prescriptions written for patients with BBS in first six weeks since FDA approval
EMA’s CHMP recommended expansion of IMCIVREE marketing authorization to include treatment of obesity and control of hunger in patients with genetically confirmed BBS; EC approval anticipated in the fourth quarter of 2022
Announced positive interim results from Phase 2 trial in hypothalamic obesity and plans to initiate Phase 3 trial in early 2023
Rhythm expects to achieve key milestones in the second half of 2022, including potential regulatory approvals and continued clinical development.