Europe Approves Lecanemab for Alzheimer's, 18-Month Study Flags 5 Risks

On August 23, Eisai and Boken announced the approval of their humanized anti-soluble aggregation amyloid-beta (Aβ) monoclonal antibody, Roncanizumab, by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for treating mild cognitive impairment and mild Alzheimer's disease (AD). This drug is indicated for adult patients, irrespective of their apolipoprotein E ε4 (ApoE ε4) carrier status.

Roncanizumab has become the first treatment in Europe aimed at addressing the underlying cause of early Alzheimer's disease, including mild cognitive impairment or mild dementia due to AD. The medication works by selectively binding to Aβ aggregates, specifically targeting the toxic fibrils. It also acts on Aβ fibers, which are the primary components of Aβ plaques, effectively neutralizing and removing these plaques from the brain.

The approval of Roncanizumab is based on data from Eisai's Phase 3 clinical study known as CLARITY AD. This study was a global, randomized, double-blind, parallel group, placebo-controlled trial. The results indicated that after 18 months, changes from baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) reached the primary endpoint, as well as all key secondary endpoints, achieving statistical significance.

In the UK, common adverse events related to Roncanizumab included infusion-related reactions, amyloid-related imaging abnormalities with bleeding (microhemorrhagic spots) known as ARIA-H, falls, headaches, and amyloid-related imaging abnormalities with cerebral edema, referred to as ARIA-E.

Eisai is collaborating with the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and the National Health Service (NHS) to ensure that this drug becomes available to eligible patients with early Alzheimer's disease as quickly as possible. The global development and registration application for Roncanizumab was spearheaded by Eisai, and the product's commercialization and promotion will be jointly undertaken by Eisai and Bojian. Regarding decision-making rights, Eisai retains the final decision-making authority.

In the UK market, Eisai and Bojian will be jointly responsible for the commercial marketing of Roncanizumab, with Eisai also handling the product's distribution as the marketing authorization holder.

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