Biogen and Eisai's Aduhelm (aducanumab-avwa) Receive the US FDA's Accelerated Approval for Alzheimer Disease
Shots:
- The approval is based on the two P-III clinical trials i.e EMERGE and ENGAGE along with P-Ib PRIME study involves assessing the efficacy of Aduhelm vs PBO in patients with early stages of AD with confirmed presence of amyloid pathology
- Results: the therapy consistently showed a dose and time-dependent effect on the reduction of amyloid-beta plaques by 59 % in ENGAGE- 71% in EMERGE- and 61% in PRIME- reduction in clinical decline- and well-characterized safety profile in ~ 3-000 patients who received at least one dose of Aduhelm
- Biogen will conduct a controlled trial to verify the clinical benefit of the therapy in patients with AD
Ref: Business Wire | Image: Biogen
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