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Regeneron表示Garetosumab治疗进展性骨质疏松性纤维发育不良的III期OPTIMA试验达到了主要终点
2025-09-17 19:09
- FOP is a disease in which muscles, tendons and ligaments are progressively replaced by bone, leading to eventual incapacitation
- Garetosmab is the first and only treatment to demonstrate a dramatic reduction in both number and volume of abnormal bone lesions (heterotopic ossification, or HO lesions) in adults with FOP
- Primary endpoint was met, showing a 90% or greater reduction in new HO lesions at 56 weeks, and garetosmab also led to a greater than 99% reduction in the total volume of new HO lesions
- Based on these data and the safety profile, the Independent Data Monitoring Committee (IDMC) recommended those receiving placebo be transitioned to garetosmab as soon as possible; U.S. regulatory submission of garetosmab in adults planned for year-end 2025
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