美国食品和药物管理局授予突破性治疗地位, The FDA grants Breakthrough Therapy status to a new MS drug showing significant benefits.

美国食品和药物管理局已授予托莱布鲁丁尼的突破性治疗指标,用于治疗非复发性次级渐进性多发性硬化症 (SPMS) 的成年人. The FDA has granted Breakthrough Therapy designation to tolebrutinib for treating adults with non-relapsing secondary progressive multiple sclerosis (SPMS). 这一指定是在第3阶段的一项研究取得积极成果之后作出的,该研究显示,与安慰剂相比,药物延迟了31%的残疾进展。 This designation follows positive results from a phase 3 study showing the drug delayed disability progression by 31% compared to a placebo. 其目的是加快药物的研制和审查,因为它有可能大大改善严重病情的治疗。 It aims to expedite the drug's development and review, given its potential to significantly improve treatment for serious medical conditions.