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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

Analysis of Larger Phase 3 Dataset

  • The Phase 3 EMERGE study met its primary endpoint, as per the pre-specified statistical analysis plan, showing a statistically significant reduction in clinical decline compared to placebo. Biogen also showed results from a subset of patients in the ENGAGE study, who were randomized to the 10 mg/kg high dose of aducanumab, that support the findings from EMERGE.

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Previously Enrolled Patients

  • The protocol of the re-dosing study that aims at offering access to aducanumab to all eligible patients who were actively enrolled in the aducanumab studies in March 2019 has been successfully submitted to the FDA. Biogen is now working with U.S. trial sites to initiate this open-label clinical trial, which does not include a placebo-controlled arm. In the U.S., we expect the first patients to be re-dosed starting in March 2020. We are also actively working in Europe and Japan to re-open sites there, and are engaging in other markets around the world, which requires seeking approval by regional regulatory authorities and institutional review boards.
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What's Next

  • Biogen plans to file a Biologics License Application with FDA in Q3 2020
  • Biogen will continue dialogue with regulatory authorities in international markets including Europe and Japan

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