ALZHEIMER'S DRUG APPROVED The U.S. Food and Drug Administration on Thursday granted traditional approval to the Alzheimer's drug lecanemab, known by the brand name Leqembi.
"Today's action is the first verification that a drug targeting the underlying disease process of Alzheimer's disease has shown clinical benefit in this devastating disease," Teresa Buracchio, acting director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, said in a news release.
"Today marks a breakthrough in the treatment of Alzheimer's disease, and we are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable," Biogen president and CEO Christopher A. Viehbacher said in a statement. The larger study tracked patients' results on an 18-point scale measuring memory and other cognitive functions. Results showed a difference of less than half a point after 18 months, sparking debate over whether this qualifies as a meaningful improvement.
"This drug is not a cure. It doesn't stop people from getting worse, but it does measurably slow the progression of the disease," Dr. Joy Snider, a neurologist at Washington University in St. Louis, told The Associated Press in January."That might mean someone could have an extra six months to a year of being able to drive."
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