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Eisai Co., Ltd. and Biogen Inc have announced that the humanised amyloid-beta (Aβ) monoclonal antibody Leqembi (Lecanemab) has been granted a Marketing Authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain.
Lecanemab is indicated for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein Eε4 heterozygotes or non-carriers. Lecanemab becomes the first treatment for early AD (MCI and mild dementia due to AD) that targets an underlying cause of the disease, to be authorised in a country in Europe according to the companies.
Lecanemab selectively binds to Aβ aggregate species, with preferential activity for toxic Aβ protofibrils. It binds to these aggregate Aβ species to neutralise and clear them from the brain.
The approval was primarily based on Phase 3 data from Eisai’s global, placebo-controlled, double-blind, parallel-group, randomised 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, fall, headache and amyloid-related imaging abnormalities with cerebral edema.
In the United Kingdom, it is estimated that 982,000 people are living with dementia, and AD is the cause in 60-70% of people with dementia. These numbers are expected to rise, as the population ages.
Eisai is working collaboratively with the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the NHS to make this medicine available to eligible people living with early AD as soon as possible.
Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercialising and co-promoting the product and Eisai having final decision-making authority. In Great Britain, Eisai and Biogen will co-promote the medicine, with Eisai distributing the product as the Marketing Authorisation holder.