EMA expected to reject marketing authorization application for Aduhelm

The news follows a negative vote trend by the Committee for Medicinal Products for Human Use (CHMP) at their oral explanation meeting.

On 17 November 2021, Biogen announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) negatively voted on the marketing authorisation application for Aduhelm. This follows an oral explanation meeting of the CHMP, with the negative decision expected to be formally adopted in their meeting later in the year (13-16 December 2021).

The EMA is responsible for authorising and monitoring medicines in the European Union and is equivalent to the Federal Drug Administration (FDA) in the United States. The CHMP committee is specifically tasked with evaluating medicines intended for human use. While not bound to the decision of the CHMP, the EMA typically adopts the same decision.

To date, Aduhelm (aducanumab) has been conditionally approved for use in the United States and the United Arab Emirates (UAE). In the official press release, Biogen’s Head of Global Safety & Regulatory Sciences and interim Head of Research & Development, Priya Singhal, M.D., M.P.H., expressed their “disappointment with the trend vote”. Despite the decision, Biogen remains committed to continuing its engagement with the EMA and CHMP as it considers its next steps in Europe.

ADI CEO Paola Barbarino said:

We understand that the news of this rejection is likely to come as a disappointment to many in our community, especially at a time when we are witnessing a reinvigorated strive for new disease-modifying therapies and research in the sector. We however remain optimistic. When the full motivation for this decision will be published we will be looking with great interest at the details We will continue to advocate for any new treatment on the market to be accessible to everyone who needs it and not just to those who can afford it.

Bookmark this page to find updates and further information on the decision as and when it becomes available.

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