Alzheimer’s Drug Wins Full FDA Approval
Lecanemab (Leqembi) became the first Alzheimer’s treatment targeted at the disease process to win full FDA approval, the agency announced today. “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,” said Teresa Buracchio, MD, acting director of the Office […]
Alzheimer’s Drug Lecanemab Wins FDA Approval
Lecanemab (Leqembi) was approved under the accelerated approval pathway to treat Alzheimer’s disease, the FDA announced on Friday. The anti-amyloid should be started only in patients with mild cognitive impairment or who are at the mild dementia stage of Alzheimer’s disease, the population studied in clinical trials, the agency noted, and the drug label indicates […]