Eisai Europe and Biogen Idec have announced the validation of a Marketing Authorisation Variation by the Medicines and Healthcare products Regulatory Agency (MHRA) for lecanemab – marketed as Leqembi®, in the UK.
The proposal aims to reduce the intravenous (IV) dosing frequency from every two weeks to every four weeks, following the initial 18-month treatment period at the approved fortnightly dose. This could provide greater flexibility for eligible adult patients with early Alzheimer’s disease (AD) and their healthcare providers.
The MHRA will now evaluate the application to decide whether to approve or reject this variation.
Lecanemab, currently licensed as a biweekly 10 mg/kg IV infusion, is developed by Eisai and Biogen to address the unmet needs of AD patients. AD, a chronic, progressive disease and the UK’s leading cause of death, often begins with symptoms such as memory loss and progresses to impair independence and daily activities.
The proposed change is part of Eisai and Biogen’s broader commitment to developing innovative solutions for managing AD, easing treatment burdens, and improving patient care. Eisai leads regulatory submissions for lecanemab globally, while both companies co-promote the treatment in the UK.
If approved, the monthly maintenance dosing could enhance treatment accessibility and flexibility, helping healthcare systems manage this complex disease more effectively. The MHRA decision is highly anticipated by clinicians and patients alike.
