Eisai Announces Promising Results for Lecanemab Subcutaneous Formulation in Early Alzheimer’s Disease

Following the highly anticipated FDA approval of the Alzheimer's drug Lecanemab intravenous injection, Eisai announced on July 20 promising study results for the Lecanemab subcutaneous injection in early Alzheimer's disease. It may offer efficacy similar to the intravenous formulation with potentially improved safety. Eisai stated that the subcutaneous injection could become "a potential new treatment option."

At a presentation during the 2023 Alzheimer's Association International Conference, researchers shared a comparative study on the exposure/bioavailability and modeling of two administration forms of Lecanemab: intravenous vs. subcutaneous.

In this study, the bioavailability of the subcutaneous formulation (the amount of active drug entering the bloodstream) was approximately 50% of that of the intravenous formulation. By integrating PK/PD modeling and bioavailability data, Eisai can select an appropriate subcutaneous injection dose.

The research team believes that a fixed subcutaneous injection dose of 720mg per week may produce exposure and efficacy comparable to the intravenous formulation, regardless of the subject's body weight, while the recommended dose for the intravenous formulation is 10mg/kg every two weeks. Based on comparable exposure, the amyloid-lowering rate of the subcutaneous injection is expected to be similar to that of the intravenous formulation.

Amyloid-related imaging abnormalities (ARIA) are side effects that cannot be avoided by all current β-amyloid antibody drugs, and may sometimes lead to serious adverse reactions, including amyloid-related imaging abnormality-edema/effusion (ARIA-E), which is associated with increased drug concentration in the blood.

Since the maximum blood concentration of Lecanemab subcutaneous injection is lower than that of intravenous injection, the incidence of ARIA-E with Lecanemab subcutaneous injection is expected to be lower.

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