MedPage Today July 6, 2023
— Decision expands lecanemab’s Medicare coverage
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 of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.”
Full FDA approval expands the drug’s Medicare coverage, giving more Alzheimer’s patients access to the drug.
Reaching this milestone in Alzheimer’s disease treatment has been “a long journey,” said Babak Tousi,...