Anavex Life Sciences Corp (AVXL)

[Steady_T]

Actually the Leqembi AA was based on a P2 trial. There was a P3 trial running at the time the NDA was filed. The P3 trial completed before the AA was granted but the FDA had not seen that data.

In May 2022, Eisai/Biogen completed lecanemab’s FDA submission, based on the Phase 2 data (May 2022 news). In July 2022, the FDA granted priority review status to the application, with a decision date of January 6, 2023 (Jul 2022 news).

On January 6, 2023, the FDA approved lecanemab under the Accelerated Approval pathway, based on evidence of effect on the surrogate endpoint of amyloid removal in the Phase 2 trial, and a reasonable likelihood of clinical benefit (FDA press release; Jan 2023 news)

https://www.alzforum.org/therapeutics/leqembi

Leqembi was approved using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is an unmet medical need and a drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. The results of a Phase 3 randomized, controlled clinical trial to confirm the drug's clinical benefit have recently been reported and the agency anticipates receiving the data soon.

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

Was that AA based on running a confirmatory P3 or P4 trial, please?