Update on Regulatory Review of Aducanumab in the European Union

About this update from Biogen Inc.

[{"type":"text","content":"CAMBRIDGE, Mass., Nov. 17, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) announced today 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. “While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Priya Singhal, M.D., M.P.H., Head of Global Safety & Regulatory Sciences and interim Head of Research & Development at Biogen. At the recent Clinical Trials on Alzheimer’s Disease conference (CTAD), Biogen announced new Phase 3 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. About ADUHELM™ (aducanumab-avwa) injection 100 mg/mL solutionADUHELM is indicated for the treatment of Alzheimer’s disease in the United States. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Aducanumab-avwa is a monoclonal antibody directed against amyloid beta. The accumulation of amyloid beta plaques in the brain is a defini...

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