BioArctic AB partner Eisai announced that Leqembi® has been granted Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain, for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. Lecanemab becomes the first the medicine which targets an underlying cause of the disease, to be authorized in a country in Europe.
"The decision from MHRA to authorize lecanemab is an important step forward for eligible patients in Great Britain who could now for the first time gain access to a treatment which in studies has been shown to slow the progression of early Alzheimer's disease. For Alzheimer's disease patients, time is the most valuable asset, and access to new treatments has potential to offer them just that," said Gunilla Osswald, CEO at BioArctic.
Lecanemab selectively binds to Aβ aggregate species, with preferential activity for toxic Aβ protofibrils (as well as fibrils, which are a major component of Aβ plaques). Lecanemab binds to these aggregate Aβ species to neutralize and clear them from the brain.
The approval was mainly based on Phase 3 data from the global Clarity AD clinical trial, in which the medicine met its primary endpoint and all key secondary endpoints with statistically significant results. In the indicated population in Great Britain, the most common adverse reactions were infusion-related reaction, amyloid-related imaging abnormalities with hemorrhage (small spots of bleeding) (ARIA-H), fall, headache and amyloid-related imaging abnormalities with cerebral edema (build-up of fluid) (ARIA-E).
It is estimated that 982,000 people live with dementia in the UK[9] and that Alzheimer's disease is the cause in 60-70% of people with dementia. These numbers are expected to increase even further with an aging population.
Eisai is working collaboratively with the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the National Health Service (NHS) to make this medicine available to eligible people living with early Alzheimer's disease as soon as possible.
Lecanemab is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region and pending European approval Eisai and BioArctic are preparing for a joint commercialization in the region.
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