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
Click here to read full press release/ article | Ref: Business Wire | Image: Stat News
The post Biogen and Eisai’s Aduhelm (aducanumab-avwa) Receive the US FDA’s Accelerated Approval for Alzheimer Disease first appeared on PharmaShots.
