19 February 2022 - The EMA refused marketing authorisation for aducanumab (Aduhelm), a monoclonal antibody targeted at amyloid β, in December 2021. 

It noted that “although Aduhelm reduces amyloid beta in the brain, the link between this effect and clinical improvement had not been established.”

Furthermore, it concluded “studies did not show that the medicine was sufficiently safe,” citing reported side effects including brain swelling and bleeding. This decision contrasts with that of the US FDA, which granted the drug accelerated approval in June 2021.

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