Rhythm Pharma says Japan regulator approves IMCIVREE for acquired hypothalamic obesity
RYTM•Phase 3 data supporting approval
The approval was backed by Phase 3 TRANSCEND data showing an 18.8% placebo-adjusted BMI reduction.
RYTM•The approval was backed by Phase 3 TRANSCEND data showing an 18.8% placebo-adjusted BMI reduction.
Rhythm Pharmaceuticals won Japan MHLW marketing authorization for IMCIVREE (setmelanotide) to treat acquired hypothalamic obesity.
Launch is targeted by the end of 2026, subject to final pricing.