Medicare

July 12 (ZFJ) — The Food and Drug Administration granted traditional approval to Eisai and Biogen’s Leqembi (lecanemab-irmb) 100 mg/mL intravenous injection on July 6. It is the first Alzheimer’s drug to clear this regulatory hurdle and aims to slow the disease’s progression. “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, acting director of the Office of Neuroscience in FDA’s Center for Drug Evaluation and Research.