FDA Advisory Committee Vote Validates LEQEMBI Alzheimer’s Treatment

FDA Advisory Committee Vote Validates LEQEMBI Alzheimer's Treatment

Source: Eisai

On June 9, 2023, the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) of the US Food and Drug Administration (FDA) unanimously voted to validate the clinical benefits of LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use in treating Alzheimer’s disease (AD). This decision was based on the comprehensive Phase III Clarity AD clinical trial conducted by Eisai, which provided compelling data. The trial successfully achieved its primary endpoint, demonstrating a remarkable and statistically significant 27% reduction in cognitive and functional decline compared to the placebo over an 18-month period.

The committee members also acknowledged the favourable benefit-risk profile of LEQEMBI and its clinical significance, discussing its potential use in specific patient subgroups such as Apolipoprotein E (ApoE) ε4 homozygous patients, patients requiring concurrent anticoagulant therapy, and patients with cerebral amyloid angiopathy.

The most common adverse events associated with LEQEMBI were infusion reactions, occurring in 26.4% of the LEQEMBI group compared to 7.4% in the placebo group. ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis) was observed in 17.3% of the LEQEMBI group compared to 9.0% in the placebo group. ARIA-E (edema/effusion) occurred in 12.6% of the LEQEMBI group compared to 1.7% in the placebo group. Other common adverse events included headache (11.1% LEQEMBI vs. 8.1% placebo) and falls (10.4% LEQEMBI vs. 9.6% placebo). It is noteworthy that the majority of infusion reactions were mild-to-moderate (96% graded as 1-2) and primarily occurred during the first dose (75%).

This groundbreaking decision by the expert panel underscores the significant progress made in the treatment of Alzheimer’s disease, with LEQEMBI demonstrating its potential to slow cognitive and functional decline in AD patients.

LEQEMBI received approval through the FDA’s accelerated approval pathway. Eisai takes the lead in the global development and regulatory submissions of lecanemab, with both companies (Eisai and the other company involved) collaborating in the commercialization and promotion of the product. Eisai holds the ultimate decision-making authority in this regard.

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