Sanofi的MS药物Tolebrutinib没有成功进行初级进步MS的主要试验,并面临美国审查的延迟。 Sanofi's MS drug tolebrutinib failed its main trial for primary progressive MS and faces delayed U.S. review.

Sanofi宣布,其口服多发性硬化药物Tlebrutinib在初级累进MS试验第3阶段未能达到其初级终点,表明残疾进展与安慰剂相比没有严重拖延。 Sanofi announced that its oral multiple sclerosis drug tolebrutinib failed to meet its primary endpoint in a Phase 3 trial for primary progressive MS, showing no significant delay in disability progression versus placebo. 在美国对不重复使用二级进步MS的监管审查中,该药物也面临延误,目前预计将在2026年Q1末作出决定。 The drug also faces a delay in U.S. regulatory review for non-relapsing secondary progressive MS, with a decision now expected by end of Q1 2026. 赛诺菲不会寻求初级进展性MS的批准,将进行损伤审查,并已提交扩展访问协议以响应FDA的要求. Sanofi will not pursue approval for primary progressive MS, will conduct an impairment review, and has submitted an expanded access protocol in response to FDA requests. 该公司对该药物其他MS表格的潜力保持信心。 The company maintains confidence in the drug’s potential for other MS forms.