Biogen Inc. and partner Eisai Co. announced that the UK Medicines and Healthcare products Regulatory Agency approved the intravenous maintenance dosing of LEQEMBI (lecanemab) on November 13, 2025, with the announcement made the following day. The approval allows patients who have completed 18 months of 10 mg/kg infusions every two weeks to switch to a 10 mg/kg dose every four weeks, or to continue the bi‑weekly schedule if preferred.
LEQEMBI had first received UK marketing authorization in August 2024 for mild cognitive impairment and mild dementia due to Alzheimer’s disease, but the National Institute for Health and Care Excellence had previously rejected its use on the NHS because of cost‑effectiveness concerns. The new maintenance‑dosing approval addresses a key patient‑centric issue—infusion‑center visits—by offering a less frequent schedule that could improve adherence and reduce logistical burdens for both patients and providers.
The expanded dosing option is expected to broaden LEQEMBI’s appeal in the UK Alzheimer’s market, which currently serves an estimated 982,000 people with dementia, 60‑70 % of whom have Alzheimer’s disease. By reducing infusion frequency, the drug may capture a larger share of this growing market, countering competition from other anti‑amyloid therapies and potentially offsetting the earlier NICE cost‑effectiveness hurdle.
From a strategic perspective, the approval strengthens Biogen’s Alzheimer’s portfolio and supports its broader effort to diversify beyond its multiple sclerosis franchise. While the announcement does not provide immediate sales figures, the ability to offer a four‑week regimen is likely to translate into higher uptake and, over time, incremental revenue growth in the UK and other markets where the drug is already approved.
The regulatory milestone underscores the progress of the global Clarity AD program, which demonstrated significant clinical benefit in Phase 3 trials. The approval also signals confidence from the MHRA in the drug’s safety and efficacy profile, potentially easing payer negotiations and improving reimbursement prospects in the UK and beyond.
Overall, the UK MHRA approval for LEQEMBI’s maintenance dosing represents a meaningful expansion of treatment options for early‑stage Alzheimer’s patients and a strategic win for Biogen and Eisai as they seek to solidify their positions in the disease‑modifying therapy market.
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