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EMA建议拒绝使用Anavex的blarcamesine治疗阿尔茨海默氏症
2025-12-12 23:58
- The European Medicine Agency is recommending that Anavex Life Sciences' (AVXL) marketing authorization application for Alzheimer's treatment blarcamesine be rejected.
- The agency said that the principal study submitted "failed to demonstrate effectiveness and safety of Blarcamesine Anavex in patients with early Alzheimer's disease who do not have a mutation in the SIGMAR1 gene," adding that the company's analysis had methodological issues.
- The EMA also said that "it was not possible to rule out the formation of nitrosamine impurities (impurities that could potentially cause cancer)."
- Anavex has 15 days to ask for a re-examination.
- Shares are down 4% in Friday trading.
More on Anavex Life Sciences
- Anavex Life Sciences Corp. (AVXL) Presents at 18th Clinical Trials on Alzheimer's Disease (CTAD-25) Conference - Slideshow
- Anavex Life Sciences: Negative CHMP Decision Does Not Bode Well For Future Approval For Alzheimer's
- Anavex Life Sciences Corp. (AVXL) Q4 2025 Earnings Call Transcript
- Anavex outlines EMA reexamination strategy and highlights blarcamesine’s long-term cognitive benefit amid regulatory setbacks
- Anavex Life Sciences GAAP EPS of -$0.11 beats by $0.04
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