STOCKHOLM, Aug. 22, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B)partner Eisai announced today that Leqembi® (brand name, generic name: lecanemab) 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)[1] heterozygotes or non-carriers.[2] 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[3] (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. [4],[5],[6]

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.[4] 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)[7], fall, headache and amyloid-related imaging abnormalities with cerebral edema  (build-up of fluid) (ARIA-E)[8],[2]

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.[10] 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.

This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons below, on August 22, 2024, at 11.05 a.m. CET.

For further information, please contact: Oskar Bosson, VP Communications and IRE-mail:  oskar.bosson@bioarctic.sePhone: +46 70 410 71 80 Jiang Millington, Director Corporate Communications and Social Media E-mail: jiang.millington@bioarctic.sePhone: +46 79 33 99 166

About lecanemab (Leqembi®)Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

Lecanemab's approval in Great Britain was primarily based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results.[2,4] Clarity AD was a Phase 3 global, placebo-controlled, double-blind, parallel-group, randomized study in 1,795 patients with early AD (MCI or mild dementia due to AD, with confirmed presence of amyloid pathology), of which 1,521 were in the indicated population in the label in Great Britain (ApoE ε4 heterozygotes or non-carriers).[2] Of the total number of patients randomized 31% were non-carriers, 53% were heterozygotes and 16% were homozygotes.1 The treatment group was administered lecanemab 10 mg/kg bi-weekly, with participants allocated in a 1:1 ratio to receive either placebo or lecanemab for 18 months.[2]

The primary endpoint was the global cognitive and functional scale, CDR-SB.[2] In the Clarity AD clinical trial, treatment with lecanemab, in the indicated population in Great Britain (ApoE ε4 heterozygotes or non-carriers), reduced clinical decline on CDR-SB by 33% at 18 months compared to placebo.[2] The mean CDR-SB score at baseline was approximately 3.2 in both groups.[2] The adjusted least-squares mean change from baseline at 18 months was 1.15 with lecanemab and 1.73 with placebo (difference, −0.58; 95% confidence interval [CI], −0.81 to −0.34; P