Shots:
- The US FDA has approved Atebrioz (100mg, PO, QD) tablets to reduce the volume of total new heterotopic ossification (HO) in pts (≥12yrs.) with FOP, & issued a Rare Pediatric Disease PRV to Incyte. MAA is under EMA’s review
- Approval was based on Cohort 1 of the P-II (PROGRESS) study, where at Wk. 24, mean total new HO lesion volume decreased by 3.2 cm³ with zilurgisertib vs a 24.6 cm³ increase with PBO, with treatment effects maintained through Wk. 48 of the OLE study
- PROGRESS program continues to advance, with enrollment completed in Cohort 2 of children (6 to <12yrs.) & underway in Cohort 3 (2 to <12yrs.). Atebrioz will be available through Mirum Access Plus, with US commercial availability expected in Oct 2026
Ref: Businesswire | Image: Mirium & Incyte | Press Release
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