Biogen Announces European Commission Grants Marketing Authorization For QALSODY To Treat SOD1-ALS In Adults; Maintains Orphan Designation
Biogen Announces European Commission Grants Marketing Authorization For QALSODY To Treat SOD1-ALS In Adults; Maintains Orphan Designation
Biogen宣佈歐盟委員會授予QALSODY的上市許可，用於治療成人 SOD1-ALS；維持孤兒稱號
- SOD1-ALS is a devastating, uniformly fatal, and ultra-rare genetic form of ALS estimated to affect less than 1,000 people in Europe1
- QALSODY is Biogen's third rare disease therapy to be approved in the EU, demonstrating the company's commitment to addressing diseases with a high unmet need
- With QALSODY, Biogen has helped advance neurofilament as a tool to optimize clinical trial design in ALS, offering the potential to expedite further breakthroughs in the field
- SOD1-ALS 是一種毀滅性的、致命性的、極爲罕見的肌萎縮性側索硬化症遺傳形式，估計影響歐洲不到 1,000 人1
- QALSODY是Biogen第三種獲得歐盟批准的罕見疾病療法，這表明了該公司致力於解決需求未得到滿足的嚴重疾病
- 通過QALSODY，Biogen幫助推動了神經絲作爲優化ALS臨床試驗設計的工具的發展，這爲加快該領域的進一步突破提供了潛力
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