BioArctic and Eisai’s Leqembi gains approval in China

10 Jan 2024
www.pharmaceutical-technology.com
Clinical ResultDrug ApprovalPhase 3
BioArctic and Eisai’s Leqembi gains approval in China
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Source: Pharmaceutical Technology
Lecanemab treats MCI due to Alzheimer’s disease and mild AD dementia. Credit: CGN089 / Shutterstock.com.
BioArctic AB and its partner Eisai have announced the approval of the amyloid beta-directed antibody Leqembi (lecanemab-irmb) in China to treat mild cognitive impairment (MCI) associated with Alzheimer’s disease (AD) and mild AD dementia.
China is the third country to approve the drug for marketing, after the US and Japan.
In July and September 2023, the US and Japanese regulatory authorities respectively approved the drug.
Leqembi, developed in partnership with BioArctic, will be made available in the region in the third quarter of 2024. Eisai will be responsible for distribution and information provision works through expert medical representatives.
The approval in China is based on results from the international Phase III Clarity AD study.
Leqembi met its primary and key secondary endpoints with statistically significant outcomes.
Leqembi treatment also reduced clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB), a cognitive and functional scale, by 27% at 18 months compared with placebo.
Infusion reactions, combined cerebral microhaemorrhages and superficial siderosis were the most frequently seen adverse events linked to Leqembi.
The drug is the first and only approved therapy demonstrated to decelerate the disease progression rate, as well as the cognitive and functional decline.
Eisai now manages the clinical development, regulatory work and marketing of the treatment.
BioArctic is eligible to receive payments for specific regulatory approvals, sales-based milestones and royalties on global product sales.
The company also retains the right to market lecanemab in the Nordic region, subject to European approval.
Eisai has now sought approval for lecanemab in 11 countries and regions, including the European Union, Canada and Great Britain.
The companies entered a long-term partnership to develop and market drugs for Alzheimer’s treatment in 2005 and, in 2007, made a deal for lecanemab.
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