Biogen’s Aduhelm (aducanumab) Granted Accelerated Approval for Alzheimer’s Disease

Biogen’s Aduhelm (aducanumab) Granted Accelerated Approval for Alzheimer’s Disease

Biogen and collaboration partner Eisai announced the U.S. FDA has granted accelerated approval for Aduhelm (aducanumab-avwa) for the treatment of Alzheimer’s disease. The accelerated approval was based on data from clinical trials demonstrating the effect of Aduhelm on reducing amyloid beta plaques, thus leading to a reduction in clinical decline. Continued approval for Aduhelm may be contingent upon verification of clinical benefit in confirmatory trial(s).

The development path for Aduhelm has been a rocky one. In March 2019, Biogen and Tokyo-based Eisai announced they were discontinuing the global Phase III clinical trials, ENGAGE and EMERGE, in patients with mild cognitive impairment for Alzheimer’s and mild Alzheimer’s dementia. The EVOLVE Phase II trial and the long-term extension PRIME Phase Ib trial were also discontinued. The decision was made based on the recommendation of an independent data monitoring committee, which indicated the trials were unlikely to hit their primary endpoint. 

However, in October 2019, the two companies announced plans to pursue regulatory approval for the drug, as the Phase III EMERGE trial met its primary endpoint, sho...

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