New Alzheimer’s drug gets full FDA approval

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.