The FDA approved once-daily oral zilurgisertib for FOP in patients aged 12 years and older after the phase 2 PROGRESS trial showed reduced new heterotopic ossification vs placebo.
Approval is based on 36-week data from BRAVE-AA-PEDS, in which 42% of patients on the 4 mg dose achieved a SALT score of 20 or less, compared with 5% on placebo.