UK regulators are set to review a proposed label update for Eisai (TYO: 4523) and Biogen’s (Nasdaq: BIIB) Alzheimer’s drug Leqembi (lecanemab), potentially opening the door to a once-monthly maintenance dosing option.
The UK arm of the Japanese pharma major Eisai and US biotech Biogen confirmed that the Medicines and Healthcare products Regulatory Agency (MHRA) has accepted the companies’ application to vary the current marketing authorization for the drug. Leqembi is currently approved in the UK as a twice-monthly intravenous infusion.
If the MHRA agrees to the proposed change, patients who have already completed 18 months of treatment on the current dosing schedule may be able to switch to a once-every-four-weeks regimen.
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