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# Biogen Says Data Show Aduhelm Working Over 2 Years
- URL: https://www.fdaweb.com/biogen-says-data-show-aduhelm-working-over-2-years/
- Published: 2022-03-16T12:00:00.000Z
- Updated: 2026-09-14T17:36:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151381

Biogen says new data show that after 128 weeks of Aduhelm (aducanumab-awwa) treatment, patients in the long-term extension phase of Phase 3 trials “continued to experience reductions in two key Alzheimer’s disease pathologies….” A company [statement](https://investors.biogen.com/news-releases/news-release-details/long-term-phase-3-data-show-aduhelmr-continues-reduce-underlying?ref=fdaweb.com) said the data were “meaningful findings, which further our understanding of amyloid and downstream biomarkers … in Alzheimer’s disease and can help inform how long patients may benefit from treatment to reduce amyloid beta plaque. These data demonstrate that long-term treatment with Aduhelm continues to reduce the underlying pathologies of Alzheimer’s disease beyond two years.”

A second company [statement](https://investors.biogen.com/news-releases/news-release-details/biogen-announces-peer-reviewed-publication-aduhelmr-phase-3?ref=fdaweb.com) said peer-reviewed Phase 3 EMERGE and ENGAGE trial data were published in *The Journal of Prevention of Alzheimer’s Disease*. Company officials said the publication will help doctors better understand the appropriate use of Aduhelm. It includes results from the primary, secondary, and tertiary endpoints in the trials, as well as safety data and biomarker sub-studies.

The FDA 6/7/21 accelerated approval of Aduhelm ignited a firestorm of [criticism](https://www.fdaweb.com/uproar-greets-fdas-aduhelm-ok-for-alzheimers/) that led to the resignation of several advisory committee members. In the aftermath, then-acting commissioner **Janet Woodcock** [said](https://www.fdaweb.com/woodcock-aduhelm-process-could-have-been-better/) the process could have been better handled and called for an HHS Office of Inspector General [review](https://www.fdaweb.com/woodcock-asks-for-oig-review-of-alzheimers-approval/).