Date:
July 12, 2021
Issue #:
1628
Summary:
Aducanumab-avwa (Aduhelm – Biogen/Eisai), an
IV amyloid beta-directed monoclonal antibody,
has received accelerated approval from the FDA
for treatment of Alzheimer’s disease. The approval
was based on the surrogate endpoint of reduction in
amyloid beta plaques in the brain. The manufacturer
is required to conduct an additional randomized
controlled trial to establish that reducing amyloid
beta plaques with aducanumab improves clinical
outcomes in patients with Alzheimer’s disease.
IV amyloid beta-directed monoclonal antibody,
has received accelerated approval from the FDA
for treatment of Alzheimer’s disease. The approval
was based on the surrogate endpoint of reduction in
amyloid beta plaques in the brain. The manufacturer
is required to conduct an additional randomized
controlled trial to establish that reducing amyloid
beta plaques with aducanumab improves clinical
outcomes in patients with Alzheimer’s disease.
