EMA refuses marketing authorisation application for Aduhelm

This follows the result of the negative vote trend by the Committee for Medicinal Products for Human Use (CHMP) at their oral explanation meeting in November.

In an update to the original news story below, Biogen announced on 22 April the decision to withdraw its marketing authorisation application for Aduhelm, following interactions with the EMA’s Committee for Medicinal Products for Human Use (CHMP) which indicated that the data presented would not be sufficient to support a positive opinion.
ADI is continuing to monitor developments with filing applications globally and will continue to update.

On 17 December 2021, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) refused the marketing application for Aduhlem (aducanumab). This follows the announcement of a negative vote trend adopted by the CHMP at their oral hearing in November.

In their announcement, the EMA noted that “although Aduhelm reduces amyloid beta in the brain, the link between this effect and clinical improvement had not been established. Results from the main studies were conflicting and did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease.” The EMA also cited issues with the safety data and the ability to monitor and manage side effects in clinical practice.

Just yesterday, Biogen committed to a new Phase 4 confirmatory study for Aduhelm as a post-marketing requirement of the FDA’s accelerated approval. The study will enrol more than 1,300 people living with early Alzheimer’s disease, with the primary completion date for the study expected to be approximately four years after the study begins.

On the EMA announcement, Charlotte Maule, Patient Advocacy Alzheimer’s Disease, Biogen said:

Although this news is very disappointing for the Alzheimer’s disease community, we are not giving up and will work to ensure European patients have access to innovative treatments for Alzheimer’s disease… We are extremely grateful to the patients, caregivers and clinicians who participated in our clinical trials, which deepened the understanding of science behind this complex disease… As part of the re-examination process, we will seek to address the CHMP’s grounds for refusal, with the goal of making this medicine available in the EU.

We at ADI know that many reading this will be disappointed by the decision today but we continue to have hope. This is especially because we are witnessing a reinvigorated strive for new disease-modifying therapies and for research in the sector and the opportunities for new therapeutics coming in 2022.

We will continue to provide further information on this process as and when it becomes available.

Read more related content