Austria and Germany to become the first markets in the European Union (EU) to launch LEQEMBI® (lecanemab)

Following the EC approval, Eisai has been collaborating with the regional and local healthcare authorities to implement the mandatory authorisation requirements ahead of launch. The required controlled access program** is now in place in Austria and Germany, enabling the launch in these first two EU countries.

AD is a progressive, relentless disease with Aβ and tau as hallmarks. AD progresses in stages that increase in severity over time, and each stage of the disease presents different challenges for those living with AD and their care partners. There is a significant unmet need for new treatment options that slow the progression of AD by initiating therapy from its early stage and continuing it in order to reduce the overall burden on people affected by AD and society. Only LEQEMBI fights AD in two ways - targeting both amyloid plaque and protofibrils***, which can impact tau downstream.

In the Clarity AD clinical trial, the primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating – Sum of Boxes (CDR-SB).¹ Treatment with lecanemab (n=757), in the EU indicated population (ApoE ε4 non-carriers or heterozygotes, measured by controlled-based multiple imputation^†), reduced clinical decline on CDR-SB by 31% at 18 months compared to placebo (n=764).¹

In the EU indicated population (ApoE ε4 non-carriers or heterozygotes) (n=757), the most common adverse reactions were infusion-related reaction (26%), ARIA-H (13%), headache (11%) and ARIA-E (9%). Symptomatic ARIA-E occurred in 2% of participants. Symptomatic ARIA-H occurred in 0.8% of patients.¹

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. In the EU (excluding the Nordic countries), Eisai and Biogen will co-promote the medicine, with Eisai distributing the product as the Marketing Authorization Holder.

* Apolipoprotein E is a protein involved in the metabolism of lipid in humans. It is implicated in AD. People with only one (heterozygous) or no copy (non-carriers) of the ApoE ε4 gene are less likely to experience ARIA than people with two ApoE ε4 copies (homozygous).² ARIA is a recognized important side effect with lecanemab that involves swelling and potential bleeding in the brain.^{1, 2}

** Controlled access program is a system that restricts the use and distribution of certain medicines. It is designed to promote the appropriate use of medicines while ensuring patient safety. In line with the EC approval requirements, initiation of lecanemab treatment should be through a central registration system implemented as part of CAP.

*** Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.³ Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.^{3, 4}

^† As requested by the regulatory authority, efficacy analyses were conducted for ApoE ε4 non-carriers or heterozygotes participants using control-based multiple imputation method, in which all missing values were imputed with copy-increments (change between visits) using the actual value in placebo group.⁵ This methodology differs from that used in the Clarity AD primary analysis which used mixed-model repeat measures (MMRM) with missing at random assumption.²

Leqembi^®▼ : This medicine is subject to additional monitoring. This allows for rapid identification of new findings on safety. Healthcare professionals are asked to report any suspected side effects.

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