Biogen Withdraws Application Seeking Approval of Aduhelm in EU

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by Marisa Wexler MS |

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Biogen has withdrawn its application seeking approval of Aduhelm (aducanumab) to treat early Alzheimer’s disease in the European Union.

A committee of the European Medicines Agency (EMA) recommended against approving Aduhelm late last year. Biogen had requested a re-examination of that decision, made by the Committee for Medicinal Products for Human Use (CHMP), but now the company has withdrawn the application after interactions with the committee indicated that data provided thus far would not be enough to support a recommendation for approval.

“We are thankful to the patients, caregivers and physicians that supported the re-examination process as part of the EMA review,” Priya Singhal, MD, Biogen’s head of global safety and regulatory sciences and interim head of research and development, said in a press release.

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Aduhelm is a monoclonal antibody designed to clear amyloid plaques, which are irregular tangles of protein found in the brains of Alzheimer’s patients that are thought to drive the disease. Clinical trials have shown that Aduhelm can reduce amyloid levels, but two large Phase 3 trials that set out to test its effect on slowing cognitive decline found inconsistent results.

The U.S. Food and Drug Administration (FDA) last year granted Aduhelm approval for early Alzheimer’s through its accelerated approval pathway. This decision basically allowed Aduhelm to be marketed in the U.S., while also requiring the therapy’s makers — Biogen and Eisai — to conduct further tests of efficacy for slowing cognitive decline.

The FDA’s decision to give Aduhelm accelerated approval was extremely contentious, triggering a congressional investigation and prompting members of an advisory committee to resign in protest. A recent decision that Medicare (the government program that insures the elderly in the U.S.) would only cover the cost of Aduhelm for individuals participating in select clinical trials has also sparked controversy.

Biogen is gearing up to launch a Phase 4 clinical study, called ENVISION, to further test the therapy in people with Alzheimer’s disease.

“We stand by the safety and efficacy of aducanumab, and we look forward to upcoming data readouts to continue to provide important information on the science of this new class of compound,” Singhal said.