This Friday, the Food and Drug Administration (FDA) approved lecanemab, a new drug developed to treat Alzheimer's disease.
The drug created by U.S.-based company Biogen and the Japanese company Eisai focuses on slowing cognitive decline in patients in the early stages of Alzheimer's.
It is "the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease," the FDA explained.
According to the government agency's press release, lecanemab went through the Accelerated Approval pathway for severe conditions which accepts clinical endpoints such as laboratory measurements, radiographic images, and other signs that predict the drug's benefits. The actual effects are not confirmed due to the number of years this could take.
"The results of a Phase 3 randomized, controlled clinical trial to confirm the drug's clinical benefit have recently been reported and the agency anticipates receiving the data soon," the FDA reported.
Breaking: FDA grants accelerated approval of Leqembi (lecanemab) for treatment of the early stages of Alzheimer’s with confirmation of amyloid beta. This is a milestone achievement for those eligible for treatment, their families & the research community. https://t.co/HuGINgcyUh
— Alzheimer's Association (@alzassociation) January 6, 2023
The study
Experts in the field conducted a controlled study based on two groups of Alzheimer's patients: one was dosed with the new drug treatment and the other was given a placebo.
The FDA website reported that "Patients receiving the approved dose of lecanemab (...) having a statistically significant reduction in brain amyloid plaque from baseline to Week 79 compared to the placebo arm, which had no reduction of amyloid beta plaque."
Side effects
The research also found that about 6.9% of people who received the new drug intravenously during the study had side effects such as temporary swelling in some areas of the brain, headaches, dizziness, confusion, nausea, seizures, and vision changes.
