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Accelerated FDA review for possible Alzheimer’s drug

Accelerated FDA review for possible Alzheimer’s drug

A potential Alzheimer’s treatment has been granted ‘priority review’ status by America’s medicines regulator, speeding up the approval decision-making process. US-quoted Biogen (US:BIIB) and Tokyo-listed Eisai (TYO:4523) revealed last Friday that the Food and Drug Administration (FDA) had accepted an application for their investigational therapy ‘aducanumab’, with a decision expected by 7 March next year. According to the companies, which have worked together on the development and commercialisation of aducanumab since 2017, the FDA has said that “if possible, it plans to act early on this application”.

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