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# Biogen Pulls European Submission on Alzheimer’s Drug
- URL: https://www.fdaweb.com/biogen-pulls-european-submission-on-alzheimers-drug/
- Published: 2022-04-22T12:00:00.000Z
- Updated: 2026-09-14T17:41:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151660

Biogen has withdrawn a European marketing authorization application for its troubled Alzheimer’s drug aducanumab. This is the latest chapter for the therapy, which gained FDA accelerated approval 6/7/21 that ignited a firestorm of [criticism](https://www.fdaweb.com/uproar-greets-fdas-aduhelm-ok-for-alzheimers/) and 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/).

Earlier this month, CMS issued its long-awaited [National Coverage Determination](https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.cms.gov%2Fmedicare-coverage-database%2Fview%2Fncacal-decision-memo.aspx%3Fproposed%3DN%26ncaid%3D305&data=04%7C01%7CRaymond.Thorn%40cms.hhs.gov%7Cb6d2aacdb7ea451176e808da18bb7f29%7Cd58addea50534a808499ba4d944910df%7C0%7C0%7C637849490840989575%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=NlkqXQiSw%2FO1TKWzMcDk%2BakYRZFGyQqXfRs6PhvZUx8%3D&reserved=0&ref=fdaweb.com) (NCD) on Medicare coverage of only FDA traditionally approved monoclonal antibodies that target amyloid (or plaque) for treating Alzheimer’s disease, a significant blow to Biogen’s aducanumab. Additionally, CMS says that as part of its NCD it will provide “enhanced access and coverage for people with Medicare participating in CMS-approved studies, such as a data collection through routine clinical practice or registries.”

With the European submission, the company says it withdrew the application following interactions with EMA’s Committee for Medicinal Products for Human Use “indicating that the data provided thus far would not be sufficient to support a positive opinion on the marketing authorization of aducanumab by EMA.” Biogen’s submission had been under review in response to the company’s request for a re-examination of a negative opinion by regulators in December.