UK MHRA expands Rhythm’s IMCIVREE authorization to treat acquired hypothalamic obesity
RYTM•UK authorization expanded for acquired hypothalamic obesity
- UK MHRA expanded IMCIVREE (setmelanotide) authorization for acquired hypothalamic obesity in patients aged 4 and older.
- The decision also granted orphan drug designation for acquired hypothalamic obesity.
- Phase 3 TRANSCEND showed a -19.8% placebo-adjusted BMI reduction at 52 weeks (p<0.0001).
- Rhythm plans to work with the NHS to finalize coverage guidance for the new indication.
