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Biogen/Eisai’s Alzheimer’s disease drug granted full FDA approval

July 7, 2023


The drug, Leqembi (lecanemab-irmb), was authorised for use in patients with mild cognitive impairment (MCI) or early-stage Alzheimer’s disease earlier this year through the accelerated approval pathway, under which the FDA may approve drugs for serious conditions where there is an unmet medical need.

This decision was based on phase 2 data showing that Leqembi reduced the accumulation of amyloid beta plaque in the brain – a defining feature of Alzheimer’s disease. However, only US residents with appropriate medical insurance, or those who could afford to pay for it directly, could access the drug.

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