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New Alzheimer’s drug gets full FDA approval

Leqembi has proven to slow the progression of the disease, while others only target its symptoms

Senior Culture Editor

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Clinical research to develop a possible cure for Alzheimer's and dementia in the lab. (TEK IMAGE/SCIENCE PHOTO LIBRARY/GETTY IMAGES)
Clinical research to develop a possible cure for Alzheimer's and dementia in the lab. (TEK IMAGE/SCIENCE PHOTO LIBRARY/GETTY IMAGES)

On Thursday, the Food and Drug Administration granted full approval for the manufacture of an innovative new Alzheimer’s drug called Leqembi — made by Japanese drugmaker Eisai and U.S.-based drugmaker Biogen — which has proven to slow the progression of the disease. While other drugs that have come before it mainly attack symptoms, Leqembi “targets a type of protein in the brain called beta-amyloid, long thought by scientists to be one of the underlying causes of Alzheimer’s disease,” according to NBC News.

“In real-world terms, this likely means more time for the patient to be living independently, enjoying their hobbies, their friends and having a better quality of life,” said Donna Wilcock, the assistant dean of biomedicine at the University of Kentucky. “Time will tell how much, but the clinical trial did show significant benefit on activities of daily living measures.” As NBC points out, there have been concerns as to the safety of the drug, which will be packaged with the FDA’s strongest warning label.

“The odds for brain swelling and hemorrhage are far higher than any actual improvement,” said Dr. Alberto Espay, a neurologist at the University of Cincinnati College of Medicine. The cost of the drug is also a factor — averaging out at $26,500 a year — as well as the three patients who died during clinical trials, but the overall promise of prolonged mental functionality outweighs those concerns for many. “Leqembi’s traditional approval is a ray of hope for millions of patients who are doing everything in they can to enhance and extend their lives and reduce their families’ burdens,” said George Vradenburg, chairman and co-founder of the patient advocacy group UsAgainstAlzheimer’s.

By Kelly McClure

Kelly McClure is Salon's Senior Culture Editor, where she helps further coverage of TV, film, music, books and culture trends from a unique and thoughtful angle. Her work has also appeared in Vulture, Vanity Fair, Vice and many other outlets that don't start with the letter V. She is the author of one sad book called "Something Is Always Happening Somewhere." Follow her on Bluesky: @WolfieVibes

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