Bioarctic's Partner Eisai's Application for Lecanemab Approval Receives Positive Recommendation in the EU

Lecanemab, a potential treatment for Alzheimer's disease, has received a positive recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The CHMP's recommendation is based on the results of the Phase 3 Clarity AD trial, which showed that lecanemab significantly slowed cognitive decline in patients with early Alzheimer's disease.

If approved by the European Commission, lecanemab would be the first new drug for Alzheimer's disease to be approved in nearly 20 years. The drug is a monoclonal antibody that targets amyloid beta, a protein that forms plaques in the brains of people with Alzheimer's disease. The plaques are thought to contribute to the cognitive decline and memory loss that are characteristic of the disease.

In the Clarity AD trial, lecanemab was shown to reduce the rate of cognitive decline by 27% compared to placebo. The drug was also shown to reduce the levels of amyloid beta in the brain and to improve the function of the brain's memory and learning centers.

The CHMP's positive recommendation is a significant step forward for lecanemab. The European Commission is expected to make a final decision on the drug's approval in the coming months.

Additional Information on Lecanemab

Lecanemab is a humanized monoclonal antibody that targets amyloid beta protofibrils, which are toxic assemblies of amyloid beta oligomers that are thought to play a key role in the pathogenesis of Alzheimer's disease.

Lecanemab is administered intravenously every two weeks. The drug is generally well-tolerated, with the most common side effects being infusion-related reactions, headache, and amyloid-related imaging abnormalities (ARIA).

The Clarity AD trial was a Phase 3, randomized, double-blind, placebo-controlled trial that enrolled 1,795 patients with early Alzheimer's disease. The trial participants were randomized to receive either lecanemab or placebo for 18 months.

The primary outcome of the Clarity AD trial was the change in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score at 18 months. The CDR-SB is a measure of cognitive function that is commonly used in Alzheimer's disease clinical trials.

The results of the Clarity AD trial showed that lecanemab significantly slowed cognitive decline in patients with early Alzheimer's disease. The drug was also shown to reduce the levels of amyloid beta in the brain and to improve the function of the brain's memory and learning centers.

The CHMP's positive recommendation for lecanemab is based on the results of the Clarity AD trial. The European Commission is expected to make a final decision on the drug's approval in the coming months.