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FDA updates the prescribing information for aducanumab, limiting it to people with MCI or mild AD

Thursday 08 July 2021

On 8 July, Biogen and Eisai announced that the FDA had approved an updated label for aducanumab, narrowing the prescribing instructions to specify the population studied in the clinical trials for the drug. The new prescribing information now includes the following phrase: "(treatment with aducanumab)..should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of disease than were studied." Aducanumab was approved by the FDA via its Accelerated Approval pathway, based on clinical trial data showing that aducanumab could reduce amyloid plaques in the brains of people treated with the drug.   

Regulatory authorities including the European Medicines Agency, the UK Medicines and Healthcare products Regulatory Authority and Swissmedic are currently reviewing aducanumab for use in their respective regions.   

https://investors.biogen.com/news-releases/news-release-details/fda-approves-updated-aduhelmtm-prescribing-information-emphasize

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