Biogen Inc. has notified the European Medicines Agency (EMA) of its decision to withdraw its Marketing Authorization Application (MAA) for aducanumab for the treatment of the early stages of Alzheimer’s disease.
The company withdrew its application following interactions with EMA’s Committee for Medicinal Products for Human Use (CHMP) 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 MAA had been under review by the CHMP in response to the company’s request for a re-examination of the negative opinion the regulatory body issued in December 2021.
Priya Singhal, M.D., M.P.H., Head of Global Safety & Regulatory Sciences and interim Head of Research & Development at Biogen, said:
We are thankful to the patients, caregivers and physicians that supported the re-examination process as part of the EMA review. 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.
Biogen will continue to advocate for patients and remains committed to research and development, as well as to its collaboration with Eisai, working towards the goal of bringing new treatment options to people living with Alzheimer’s disease.
ADUHELM (aducanumab-avwa) was approved by the U.S. Food and Drug Administration (FDA), under the accelerated approval pathway, for the treatment of Alzheimer’s disease. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Further details on the indication are provided below.
From 2017 to March 13, 2022, Biogen and Eisai jointly collaborated on the development, commercialization and manufacturing of ADUHELM. Effective March 14, 2022, Biogen has sole decision-making authority over the development, commercialization and manufacturing of ADUHELM. In 2022 the parties will continue in a global profit/loss sharing arrangement subject to a cap on Eisai’s expenses for 2022. Eisai will be entitled to a tiered royalty on net sales of ADUHELM as of January 1, 2023.