Lecanemab (also known as Leqembi) is a monoclonal antibody drug that is being developed by Biogen as a treatment for Alzheimer’s disease. It is designed to target a protein called amyloid-beta, which is thought to play a role in the development of Alzheimer’s. Lecanemab works by binding to amyloid-beta and helping to clear it from the brain.
The drug is currently in clinical trials, and early results have been promising. In a phase 2 clinical trial, lecanemab was shown to reduce amyloid-beta levels in the brain and improve cognitive function in patients with Alzheimer’s disease. Larger phase 3 clinical trials are currently underway to further evaluate the safety and effectiveness of lecanemab.
The FDA grants accelerated approval for lecanemab
The lecanemab drug for slowing the progression of Alzheimer’s disease in a patient’s body has received accelerated approval from the US Food and Drug Administration (FDA), according to the federal agency’s website.
Billy Dunn, M.D., the director of the Office of Neuroscience in the Center for Drug Evaluation and Research of the FDA, explained:
Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,
This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.
Leqembi received approval through the FDA’s Accelerated Approval pathway, which allows for the approval of drugs for serious conditions where there is a lack of available treatment options, and the drug demonstrates an effect on a surrogate endpoint that is expected to indicate a clinical benefit for patients. A Phase 3 clinical trial designed to confirm the drug’s clinical benefit has recently been completed, and the data is expected to be received by the agency in the near future.
According to the World Health Organization (WHO), an estimated 50 million people worldwide have Alzheimer’s disease, and this number is expected to triple by 2050.
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