Replies to post #429688 on Anavex Life Sciences Corp (AVXL)

[Doc328]

Biogen's AA was 10 months after the NDA was submitted.

Actually, Eisai/Biogen had the Accelerated Approval BLA (biologic equivalent of NDA) accepted for review on July 5, 2022 and was concurrently granted priority review. 6 months later they got accelerated approval (Jan 5,2023) and they received conventional approval July 6, 2023. Breakthrough therapy had previously been granted in 2021 which allowed rolling submission

I think its very noteworthy that not only was the phase 3 initiated before AA in January, the TLD had been released at CTAD end of November AND a peer reviewed NEJM article of the phase 3 was out. Therefore, AA approval was low risk for the FDA. They took only 8 weeks after the end of study to report TLD at CTAD.

PR's:
BLA acceptance with Priority review
https://investors.biogen.com/news-releases/news-release-details/us-fda-accepts-and-grants-priority-review-eisais-biologics

Accelerated approval
https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment

Traditional approval
https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval

P3 publication
https://www.nejm.org/doi/full/10.1056/NEJMoa2212948 (originally published online November 29, 2022)