Biogen Halts Aduhelm’s Second EU Marketing Application

On April 22, Biogen announced that it withdrew its marketing application for the Aduhelm drug in Europe after failing to convince the EMA’s Committee for Medicinal Products for Human Use (CHMP). Facing restricted coverage by the U.S. Centers for Medicare & Medicaid Services earlier this month, the news came as another blow to Aduhelm’s treacherous journey to reach patients.

The biotech said the decision follows interactions with the European Medicines Agency that suggested data supplied would be insufficient to support an approval. Biogen’s European Marketing Authorisation Application (MAA) had been under CHMP review in response to the company’s request for a re-examination of the negative review issued back in December.

“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,” said Priya Singhal, Biogen’s interim Head of R&D.

Related Article: EMA Rejects Marketing Authorization Application of Aduhelm

Lacking Efficacy Results in Previous Submission

In December 2021, the EMA determined that while Aduhelm reduces amyloid beta in the brain, the link between effect and clinical improvement had not been established. Results from studies were conflicting and did not show overall that Aduhelm was effective in adult patients with early-stage Alzheimer’s disease. Conclusively, the agency deemed that Aduhelm’s benefits did not outweigh its risks and thus recommended against marketing authorization.

The drug was approved in the United States last June, a contented decision considering only one of two late-stage trials demonstrated that it helped slow cognitive decline. The FDA ruling was based on the Aduhelm’s ability to remove amyloid plaque from the brain, which the agency said is likely to slow cognitive decline for early Alzheimer’s patients. 

Eli Lilly and Co, Roche Holding AG, and Eisai Co Ltd also have plaque-removing drugs in late-stage development.

Author

Fujie Tham