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Aducanumab is an investigational drug and is not approved for use in the U.S. or any other country.

Biogen Plans Regulatory Filing for aducanumab in Early Alzheimer’s Disease

If approved, aducanumab would become the first therapy to reduce the clinical decline of early Alzheimer’s disease

Biogen plans to file for market approval in the U.S. for aducanumab based on a new analysis of a larger dataset and discussions with the U.S. Food and Drug Administration (FDA)

With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s. This is the result of groundbreaking research and is a testament to Biogen’s steadfast determination to follow the science and do the right thing for patients. We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease and the potential implication of these results for similar approaches targeting amyloid beta.

Michel Vounatsos
CHIEF EXECUTIVE OFFICER, Biogen

New Analysis of Larger Phase 3 Dataset

  • The EMERGE study met its primary endpoint, showing a significant reduction in clinical decline. We believe this is supported by data from a subset of patients in the ENGAGE study who received sufficient exposure to high dose aducanumab, though ENGAGE did not meet its primary endpoint

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Previously Enrolled Patients

  • Biogen aims to offer access to aducanumab to eligible patients who were actively enrolled in the aducanumab clinical studies in March 2019

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What's Next

  • Biogen plans to file a Biologics License Application with FDA in early 2020

  • Biogen will continue dialogue with regulatory authorities in international markets including Europe and Japan

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