Swedish research-based biopharma company BioArctic AB (STO:BIOA-B) announced on Wednesday that its partner Eisai Co Ltd (TYO:4523) has received validation from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) to evaluate a Marketing Authorisation Variation for monthly intravenous dosing of Leqembi (lecanemab).

Leqembi is currently approved in the UK for biweekly intravenous treatment for early Alzheimer's disease. The proposed change would allow eligible patients to shift to a once-monthly dosing schedule following the initial 18-month treatment phase.

This adjustment aims to increase treatment flexibility for patients and healthcare providers while maintaining therapeutic effectiveness.

The submission forms part of Eisai's broader efforts to address the unmet needs of Alzheimer's patients and ease healthcare system burdens.

Leqembi is a monoclonal antibody targeting amyloid-beta. It is approved in major markets including the United States, Japan, EU, China and the UK based on positive Phase 3 results from Eisai's Clarity AD clinical trial, where the treatment met all key endpoints.

In January 2025, the US Food and Drug Administration (FDA) approved an intravenous maintenance dosing schedule, and the FDA is currently reviewing a weekly subcutaneous autoinjector version with a decision expected by 31 August 2025.

The MHRA will now assess the proposed UK dosing variation to determine whether to grant approval.