As recently reported by Forbes, the U.S. Food and Drug Administration (FDA) approved Leqembi (lecanemab) for Alzheimer’s disease earlier this week. Leqembi is a humanized monoclonal antibody that targets and binds to beta-amyloids in the brain. These proteins can clump together and form plaques or tangles which are believed to drive Alzheimer’s progression. Initially, Leqembi received Accelerated Approval from the FDA earlier this year. 

Leqembi is approved for individuals living with early-stage Alzheimer’s disease with confirmed elevated beta-amyloid levels. It clears amyloid from the brain, preventing cognitive decline and preserving neuronal function. One clinical study even found that Leqembi reduced cognitive decline by 27% in an 18-month period. 

However, the path to approval has been fraught with issues. Some people worry that the drug’s benefits do not outweigh the risks. They point to the death that occurred within the clinical trial and expressed concerns about the drug’s potential to cause intracranial swelling and bleeding.

However, the FDA believes that this therapy—the first of its kind—does offer clinical benefit. Leqembi should be available soon through insurance, including Medicare. 

About Alzheimer’s Disease

An estimated 55 million people worldwide suffer from some form of dementia, with 60-70% of cases attributed to Alzheimer’s disease. This progressive neurodegenerative disorder causes brain cells to die. It typically begins with mild memory loss but progresses to the point where it can become difficult to complete daily tasks. 

Doctors don’t know the exact cause of Alzheimer’s disease. A blend of genetics, environmental factors, and lifestyle factors are believed to play a role. However, risk factors have been identified. If you are older than 60 years old, female, or have a relative with Alzheimer’s disease, you have a heightened risk of developing it. Symptoms can include:

• Worsening memory loss
• Changes in mood, behavior, or personality such as depression, aggression, delusions, or social withdrawal
• Decreased or poor judgment
• Newly onset problems with speech or writing
• Difficulty concentrating, thinking, or multitasking
• Aspiration (complication)
• Pneumonia (complication)
• Malnutrition and/or dehydration (complication)