布雷波西提尼在皮肤肌炎试验中显示出强的结果,达到所有目标,并为FDA批准铺平了道路. Brepocitinib shows strong results in trial for dermatomyositis, meeting all goals and paving way for FDA approval.

罗伊万特科学公司和普里万特治疗公司宣布了对皮肤肌炎治疗的布雷波西提尼布的第3期VALOR试验结果,显示在52周比安慰剂显著改善,平均总改善得分为46. 5与31.2 Roivant Sciences and Priovant Therapeutics announced positive Phase 3 VALOR trial results for brepocitinib in dermatomyositis, showing significant improvement over placebo at week 52 with a mean Total Improvement Score of 46.5 versus 31.2. 该药物达到其初级端点和所有9个二级端点,标志着该病情中定向治疗首次进行积极登记试验。 The drug met its primary endpoint and all nine secondary endpoints, marking the first positive registrational trial for a targeted therapy in the condition. 安全结果与以往试验一致,各公司计划在2026年初提交新的药物应用软件。 Safety results were consistent with prior trials, and the companies plan to submit a New Drug Application in early 2026.