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Sanofi's Tolebrutinib Achieves FDA Breakthrough Therapy Designation For Non-Relapsing Secondary Progressive Multiple Sclerosis (NrSPMS)

Sanofi's Tolebrutinib Achieves FDA Breakthrough Therapy Designation For Non-Relapsing Secondary Progressive Multiple Sclerosis (NrSPMS)

賽諾菲的Tolebrutinib獲得FDA突破性治療認定,適用於非複發性繼發性進展型多發性硬化症(NrSPMS)
Benzinga ·  12/13 14:12

Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosis

託雷布晶被FDA指定爲非複發性繼發性漸進型多發性硬化症的突破性療法。

  • Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS)
  • Tolebrutinib is the first and only brain-penetrant BTK inhibitor in MS to be designated Breakthrough Therapy by the FDA
  • 該指定基於HERCULES研究在非複發性繼發性漸進型多發性硬化症(nrSPMS)成年患者中的積極結果。
  • 託雷布晶是FDA指定爲突破性療法的多發性硬化症中首個也是唯一一個具有腦穿透能力的BTk抑制劑。

譯文內容由第三人軟體翻譯。


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