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Update on regulatory review of aducanumab ,a proposed treatment for Alzheimer's disease, in the European Union.

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Published:18th Nov 2021
Biogen Inc. and Eisai Co., Ltd. announced an update on the ongoing review of the Marketing Authorization Application for aducanumab 100 mg/mL concentrate solution for infusion for the treatment of Alzheimer’s disease by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Following an oral explanation held at the November meeting of the CHMP, Biogen received a negative trend vote on the aducanumab Marketing Authorization Application. The CHMP is expected to adopt a formal opinion on the Marketing Authorization Application at its December meeting (December 13-16, 2021). Biogen will continue to engage with the EMA and CHMP as it considers next steps towards the goal of providing access to aducanumab to patients in Europe.

At the recent Clinical Trials on Alzheimer’s Disease conference (CTAD), Biogen announced new Phase III findings that provide further evidence of aducanumab’s effect on lowering amyloid beta plaque and downstream tau pathology, the two defining pathologies of Alzheimer’s disease..

Condition: Alzheimers
Type: drug

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