Leqembi ▼ (lecanemab) proposed Marketing Authorisation Variation for monthly intravenous maintenance dosing for the treatment of early Alzheimer’s disease in the UK is validated for evaluation by the MHRA
April 30, 2025 – Other, Pharmaceutical – Alzheimer's Disease, Eisai, MHRA, marketing approval, neurodegenerative disease
- Proposed intravenous maintenance dosing application to reduce lecanemab infusion frequency from every two weeks to every four weeks for eligible adult UK patients after initial 18 months of treatment
- The variation application will be evaluated by the Medicines and Healthcare products Regulatory Agency, which will decide whether to approve or reject the proposal.
30 April 2025 — Hatfield and Maidenhead, UK — Eisai Europe and Biogen Idec announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has validated a proposed Marketing Authorisation Variation for monthly lecanemab dosing for eligible adult patients with early Alzheimer’s disease (AD) in the UK, after an initial 18 months of treatment at the currently approved dosing regimen. The variation application will now be evaluated by the MHRA to decide whether to approve or reject the proposal.
Currently, lecanemab is licenced as an intravenous (IV) infusion once every two weeks (10 mg/kg). If approved, this application may enable the dosing frequency to decrease to once every four weeks, after eligible patients have completed the initial 18 months of treatment every two weeks.
The submission is part of Eisai and Biogen’s ongoing commitment to addressing the unmet needs of people living with AD, healthcare systems and wider society. Maintenance dosing is an important step forward in providing flexibility to eligible patients and healthcare professionals in managing this chronic, progressive disease.
AD is a chronic disease which progresses in stages and increases in severity over time. AD is the leading cause of death in the UK, with early AD usually being the first stage of the disease where symptoms become noticeable, such as forgetting recent events or conversations. As AD progresses, everyday activities, hobbies and social engagements become more challenging, and independence is lost.
Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercialising and co-promoting the product and Eisai having final decision-making authority. In the UK, Eisai and Biogen co-promote the medicine, with Eisai distributing the product as the Marketing Authorisation Holder.
About Eisai EMEA
At Eisai, we give our first thought to patients, their care partners and to society, to increase the benefits health care provides them – we call this human health care (hhc). We focus beyond the realm of health to the value we bring to society. Through the power of collaboration and by using insights to guide our work, we can make a meaningful contribution to people and society, and to improve outcomes and services for all. In EMEA, we are the European hub of Tokyo-based Eisai Co. Ltd., forming part of a multinational team working across a global network of R&D facilities, manufacturing sites and marketing subsidiaries. Our collective passion and dedication to patient care is the driving force behind our efforts to discover and develop innovative medicines in a variety of therapeutic areas where a high unmet medical need remains, including oncology and neurology. Our mission is clear; we strive to make a significant long-lasting contribution to society in an ethical, compliant, and sustainable way by embodying hhc in everything we do. For more information about Eisai in the EMEA region please visit www.eisai.eu.
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities with aspirations to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. Biogen routinely post information that may be important to investors on its website: www.biogen.com.
