A marketing authorization application for lecanemab, an investigational anti-amyloid beta (A) protofibril antibody, has been submitted by BioArctic AB’s (publ) partner Eisai to the Pharmaceuticals and Medical Devices Agency for the treatment of mild cognitive impairment (MCI) brought on by Alzheimer’s disease (AD) and mild Alzheimer’s dementia (collectively known as early AD) with confirmed amyloid pathology in the brain (PMDA). BioArctic is entitled to a milestone payment of MEUR 5 in connection with the regulatory filing in Japan that was announced today and the subsequent acceptance of the file by PMDA.
This application is based on the Phase 3 Clarity AD trial and Phase 2b clinical study findings, which showed that lecanemab medication slowed the progression of early Alzheimer’s disease. In order to minimise the lecanemab review period, Eisai used the PMDA’s pre assessment consultation method before submitting this application.
As the primary objective (CDR-SB: Clinical Dementia Rating-Sum of Boxes) in the Clarity AD research, lecanemab therapy reduced clinical decline on the overall cognitive and functional scale as early as six months and over time across all time points. All relevant secondary endpoints also displayed results that were very statistically significant. In particular, lecanemab therapy demonstrated a statistically significant decrease in the burden of amyloid plaque at all timepoints beginning at three months in the amyloid PET research, as well as a statistically significant slowing of the deterioration in daily living activities on the ADCS MCI-ADL. Infusion responses, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall were the most frequent adverse events (>10%) in the lecanemab group.
The Clarity AD study’s findings were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference in November 2022 and simultaneously published in the peer-reviewed medical journal New England Journal of Medicine.
The Food and Drug Administration (FDA) gave lecanemab expedited approval as a therapy for AD on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA seeking full authorization via the conventional process. The European Medicines Agency (EMA) received an application for marketing authorization from Eisai on January 9, 2023. To the National Medical Products Administration (NMPA) in China, Eisai started submitting data for a BLA in December 2022.
Lecanemab development and regulatory submissions are overseen by Eisai, who also has final decision-making power. Eisai and Biogen jointly market and co-promote the drug. Lecanemab is currently being prepared for commercialization in the Nordics by BioArctic and Eisai. BioArctic has the legal right to market lecanemab in the Nordics under specific circumstances. Lecanemab has no associated development expenditures for BioArctic, and the company is eligible for compensation in connection with regulatory submissions, approvals, and sales milestones in addition to royalties on worldwide sales.
This release discusses investigational uses of an agent under development; conclusions about efficacy or safety are not to be drawn from it. There is no assurance that a particular investigational agent will be approved by a health authority.
According to the EU Market Abuse Regulation, BioArctic AB (publ) is required to report this information. On January 16, 2023, at 01.30 a.m. CET, the information was made available for public disclosure through the agency of the contact person listed below.
