Garetosmab
Fibrodysplasia ossificans progressiva · Adults with fibrodysplasia ossificans progressiva
REGN · Regeneron Pharmaceuticals
监管认定
完整时间线
4 个里程碑FDA decision expected
Regeneron disclosed an August 2026 FDA target action month. The structured Event Date uses August 31 as the month-end representation of this month-level disclosure.
Regeneron — BLA acceptance and August 2026 target action month↗FDA accepted the BLA with Priority Review
FDA accepted the garetosmab BLA for adults with FOP under Priority Review and set the target action date in August 2026.
Regeneron — FDA Priority Review for garetosmab↗OPTIMA met its primary endpoint
Both garetosmab doses reduced the number of new heterotopic ossification lesions by at least 90% versus placebo at Week 56, with a greater than 99% reduction in total new lesion volume.
Regeneron — Positive Phase 3 OPTIMA results↗Phase 3 OPTIMA study started
The pivotal OPTIMA study began enrolling adults with fibrodysplasia ossificans progressiva to compare two garetosmab dose regimens with placebo.
ClinicalTrials.gov — OPTIMA study record (NCT05394116)↗相关新闻
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