EUROPE – Biogen has withdrawn its application for the Alzheimer’s disease drug in the European Union after discussions with regulators revealed that the data provided thus far is unlikely to support marketing approval, the company announced.
Since receiving approval in the United States last summer, Aducanumab, also known as Aduhelm, has been mired in controversy over its data and pricing.
The drugmaker stated that the decision was made in response to interactions with the European Medicines Agency, which indicated that the data provided thus far would not be sufficient to support an approval.
The agency rejected the drug in December, and Biogen requested a re-examination of its decision.
The drug was approved in the United States last June, which was a contentious decision given that only one of two late-stage trials showed that it slowed cognitive decline.
A panel of outside experts appointed by the Food and Drug Administration had advised against approval.
The FDA made its decision based on the drug’s ability to clear amyloid plaque from the brain, which the agency believes will likely slow cognitive decline in early Alzheimer’s patients.
Meanwhile, the Centers for Medicare & Medicaid Services (CMS) confirmed this month a highly restrictive coverage plan for the drug, limiting the use of Aduhelm and other similar medications to patients enrolled in certain clinical trials.
The antibody’s accelerated approval in the United States “may be contingent on verification of clinical benefit in confirmatory trial(s),” according to Biogen in a release.
In announcing the withdrawal of its EU application, Biogen reaffirmed its commitment to Alzheimer’s research and patient advocacy, as well as its collaboration with Japanese pharmaceutical Eisai.
In March, the partners agreed on a new commercial arrangement for Aduhelm, with Eisai relinquishing marketing and Biogen assuming “sole decision making and commercialization rights” to the drug.
Eisai will discontinue its Aduhelm support role beginning next year and will no longer cut profits or losses. Eisai will instead receive a tiered royalty based on Aduhelm sales, the companies announced last month.
It’s unclear how much that royalty is worth. Aduhelm earned US$1 million in the fourth quarter of 2021 and US$3 million for the entire year.
Eli Lilly and Co, Roche Holding, and Eisai Co Ltd, which is partnered with Biogen, also have plaque-clearing drugs in late-stage development.
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