Anavex Life Sciences Corp (AVXL)

[Hosai]

"However, the FDA has acknowledged that it may take longer to establish clinically meaningful treatment effect among patients with early Alzheimer’s due to the very limited (if any) cognitive and functional deficits seen at those stages of disease. Additionally, many tools often used to measure functional impairment in patients with later stages of Alzheimer’s may not be able to identify subtle changes in early-stage disease, the agency explained.

Given these two factors, the FDA is considering other approaches, including endpoints based on cognitive assessments or surrogate endpoints, which may allow for shorter trial durations in the earliest stages of disease.

Direct measures of clinical benefit or validated surrogate endpoints may support a traditional approval, according to the FDA, while surrogate endpoints or intermediate clinical endpoints that don’t directly measure clinical benefit but are considered reasonably likely to predict clinical benefit may support the case for accelerated approval."

https://www.fiercebiotech.com/biotech/new-fda-guidelines-consider-amyloid-reduction-reasonably-likely-predict-clinical-benefit?utm_medium=email&utm_source=nl&utm_campaign=LS-NL-FierceBiotech&oly_enc_id=5901F6483778B1Z