BioArctic's Lecanemab Secures Key EU Panel Backing for Alzheimer's Treatment

CHMP recommends conditional marketing approval for the anti-amyloid beta protofibril antibody

Lecanemab has the potential to address the underlying causes of Alzheimer's disease but must be used with caution due to side effects

Lecanemab is targeting amyloid beta, the protein that forms plaques in the brains of patients with Alzheimer's. The drug is designed to reduce the levels of these plaques, thus potentially slowing down the progression of the disease.

The CHMP's positive opinion is based on data from two Phase III clinical trials, Clarity AD and AHEAD 3-45. The Clarity AD trial showed that Lecanemab reduced cognitive and functional decline in patients with early Alzheimer's disease by 27% compared to placebo. The AHEAD 3-45 trial showed that Lecanemab reduced the levels of amyloid beta plaques in the brain by 80% compared to placebo. Although, treatment with Lecanemab can cause side effects such as brain swelling and bleeding, which is why the drug must be used with caution.

The CHMP's recommendation will now be reviewed by the European Commission, which has the final say on whether to grant marketing authorization for Lecanemab. If approved, Lecanemab would be the first new Alzheimer's drug to be approved in nearly two decades. Its market potential is significant, given that an estimated 55 million people worldwide live with dementia, including Alzheimer's disease.

Alzheimer's disease is a progressive neurodegenerative disorder that affects memory, thinking, and behavior. It is the most common form of dementia, accounting for 60-80% of cases. The disease is characterized by the accumulation of amyloid beta plaques and tau tangles in the brain. These plaques and tangles disrupt the normal function of brain cells, leading to the symptoms of Alzheimer's disease.

There is currently no cure for Alzheimer's disease, but treatments are available to help manage the symptoms. These treatments include cholinesterase inhibitors, memantine, and antipsychotics. Lifestyle changes, such as exercise, a healthy diet, and cognitive stimulation, can also help to improve the quality of life for people with Alzheimer's disease.

Lecanemab is a promising new treatment for Alzheimer's disease. The drug has the potential to slow down the progression of the disease and improve the quality of life for people with Alzheimer's. The CHMP's positive opinion is a significant step towards making Lecanemab available to patients in Europe.