- Biogen has withdrawn a request to start selling its Alzheimer's disease drug in Europe, marking the latest setback in the company's efforts to ramp up slower-than-expected sales of the closely watched medicine.
- Biogen originally filed an application in 2020 with the agency that recommends whether new drugs should be approved in Europe. Near the end of 2021, the European Medicines Agency concluded there was not enough evidence to allow Biogen's drug, called Aduhelm, on the market. Biogen said it would ask for a re-examination, but, according to newly released documents from the EMA, the company withdrew its application before the review was completed.
- In a letter to European regulators, Biogen's Netherlands subsidiary said it chose to pull the approval application following interactions with an important division in the EMA. That division, according to Biogen, indicated that the Aduhelm data it had received was not be sufficient enough to warrant a recommendation for marketing approval.
Biogen's hopes for Aduhelm have dimmed on both sides of the Atlantic.
In the U.S., Aduhelm is approved, but sales have been anemic as controversy over the drug's performance in clinical trials led insurers and hospitals to push back on its use. Earlier this month, Medicare, the government program that covers many of the patients eligible for treatment, finalized a restrictive policy that limits reimbursement only to participants in randomized clinical trials. The decision was a major blow to Biogen, which had sought to overturn a similarly structured draft of the plan.
The drugs committee of the EMA previously recommended against European authorization of Aduhelm, citing "conflicting" data and concerns about its safety. Biogen appealed the decision, requesting a re-examination, but withdrew its application after it became apparent the agency's decision was not likely to change.
"This withdrawal is based on interactions with the [committee] indicating that the data provided thus far
would not be sufficient to support a positive opinion on the marketing authorization of Aduhelm," Biogen wrote in its letter to the regulator.
With Aduhelm's market potential curbed, Biogen has turned to cost cuts and layoffs. In March, the company disclosed that it had begun cutting jobs, though it did not specify how many. Previously, Stat News reported that Biogen was considering terminating more than 1,000 jobs, which would be the largest workforce reduction in the company's history.
Overall, Biogen aims to reduce annual expenses by about $500 million, although CEO Michel Vountasos has said that figure could grow further still.
Biogen may also choose to focus its resources toward another Alzheimer's drugs, which it's developing with partner Eisai. Late-stage clinical trial results are expected this year, and Eisai has already begun a rolling application for accelerated approval with the Food and Drug Administration.
Following Medicare's release of its final policy this month, Biogen said it was "carefully considering all its options" as it evaluates the decision's impact on its business.
In a statement Friday, Biogen's interim head of research and development, Priya Singhal, said the company "stands by" Aduhelm's safety and efficacy, adding that "we look forward to upcoming data readouts to continue to provide important information on the science of this new class of compound."
The company will report first quarter earnings on May 3, when it might reveal more information about its plans.