BioArctic AB‘s partner Eisai announced that the Medicines and Healthcare products Regulatory Agency in the United Kingdom has approved Leqembi, also known as lecanemab, for maintenance treatment administered once every four weeks by intravenous infusion for patients with early Alzheimer’s disease. This approval provides a new option for patients who have completed an initial 18-month course of 10 mg per kilogram every two weeks, allowing them to either transition to a once-monthly dosing schedule or continue with the previous biweekly regimen.

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Earlier in August 2024, Leqembi received approval in the United Kingdom for the treatment of mild cognitive impairment and mild dementia caused by Alzheimer’s disease in adult patients who are apolipoprotein E ε4 heterozygotes or non-carriers. The newly approved maintenance regimen adds flexibility for long-term treatment, offering healthcare providers and patients more options for ongoing care.

An estimated 982,000 people in the United Kingdom are currently living with dementia, and Alzheimer’s disease accounts for roughly 60 to 70 percent of these cases. These numbers are expected to increase in the coming years as the population continues to age, highlighting the importance of effective therapies such as Leqembi.

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Leqembi is the result of a long-term collaboration between BioArctic and Eisai. The antibody was originally developed by BioArctic following the work of Professor Lars Lannfelt, who discovered the Arctic mutation associated with Alzheimer’s disease. Eisai handles clinical development, regulatory submissions, and commercialization of Leqembi for Alzheimer’s disease.

BioArctic retains rights to commercialize Leqembi in the Nordic region alongside Eisai. Both companies are actively preparing for a joint commercialization strategy in the region to expand access to this treatment for patients living with Alzheimer’s disease.

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