ATEBRIOZ (zilurgisertib) tablets
Reduction of total new heterotopic ossification volume in fibrodysplasia ossificans progressiva · Adult and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva
MIRM · Mirum Pharmaceuticals
Regulatory designations
Full timeline
4 milestonesFDA approved ATEBRIOZ for fibrodysplasia ossificans progressiva
FDA approved ATEBRIOZ tablets to reduce the volume of total new heterotopic ossification in adult and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva.
FDA — Approval of ATEBRIOZ for fibrodysplasia ossificans progressiva↗Pivotal PROGRESS results were presented
The pivotal Phase 2 study reported reductions in heterotopic-ossification lesion measures and flare activity in adolescents and adults with FOP, with no adverse events leading to discontinuation or dose reduction.
Mirum and Incyte — Positive pivotal PROGRESS results↗Mirum disclosed the accepted NDA and licensed the program
Mirum obtained exclusive worldwide rights to zilurgisertib from Incyte and confirmed that FDA had accepted the NDA with Priority Review for patients age 12 and older.
Mirum — Zilurgisertib license and regulatory update↗Phase 2 PROGRESS study started
PROGRESS began evaluating zilurgisertib in adults with fibrodysplasia ossificans progressiva and later supplied the pivotal efficacy and safety dataset for the NDA.
ClinicalTrials.gov — PROGRESS study record (NCT05090891)↗Related News
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