Anavex Life Sciences Corp (AVXL)

[kevindenver]

Can you say FDA Accelerated Approval? I knew you could. WGT!

I've been trying to stay away from the AI to do research the hard way, but now I'm hooked with the "co-pilot" program Microsoft has forced onto our desktops.

"The surrogate biomarker for the accelerated approval of Leqembi was the **reduction in amyloid beta plaques in the brain** ¹². The FDA granted accelerated approval to Leqembi through its accelerated approval process, which requires only that a drug show benefit against a surrogate biomarker that is expected to lead to eventual clinical benefit to patients ¹4. However, the accelerated approval is based on a surrogate endpoint of reduction in brain amyloid plaques, which is a biomarker with little evidence that proves an association with clinical benefit, such as improvement in cognition ².

Source: Conversation with Bing, 11/20/2023
(1) FDA AWARDS FULL APPROVAL FOR LEQEMBI - Cure Alzheimer's Fund. https://curealz.org/news-and-events/fda-awards-full-approval-for-leqembi/.
(2) Lecanemab (Leqembi) | BCBSND. https://www.bcbsnd.com/providers/policies-precertification/medical-policy/l/lecanemab--leqembi-.
(3) FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment.
(4) Is Leqembi used to treat Alzheimer's? - Drugs.com. https://www.drugs.com/medical-answers/leqembi-treat-alzheimers-3573249/.