Leqembi (lecanemab) authorized for early alzheimer’s disease in Great Britain – Eisai + Biogen

Eisai Co., Ltd. and Biogen Inc. announced that the humanized amyloid-beta (Abeta monoclonal antibody “Leqembi” (brand name, generic name: lecanemab) has been granted a Marketing Authorization 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 E e4 (ApoE e4) heterozygotes or non-carriers. Lecanemab becomes the first treatment for early AD (MCI and mild dementia due to AD2 that targets an underlying cause of the disease, to be authorized in a country in Europe.

Lecanemab selectively binds to Abeta aggregate species, with preferential activity for toxic Abeta protofibrils (as well as fibrils, which are a major component of Abeta plaques).It binds to these aggregate Abeta species to neutralize and clear them from the brain.

The approval was primarily based on Phase III data from Eisai’s global, placebo-controlled, double-blind, parallel-group, randomized Clarity AD clinical trial, in which the medicine met its primary endpoint (change from baseline in the Clinical Dementia Rating Sum of Boxes [CDR-SB] at 18 months) 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)

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.