The U.S. Food and Drug Administration on Thursday granted full approval to the Biogen and Eisai Alzheimer’s treatment Leqembi.
Leqembi, also known as lecanemab, is the first drug shown to slow the progress of the disease, rather than just treating its symptoms.
It is a monoclonal antibody designed to reduce the buildup of amyloid beta plaque in the brain, a marker of Alzheimer’s disease.
The FDA action Thursday “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 statement.
The FDA in January granted Leqembi accelerated approval, which allows for earlier approval of drugs that treat serious conditions where there is an unmet medical need, even while studies to confirm the expected clinical benefit are ongoing.
In a late-stage trial, the treatment slowed declines in cognition and function by 27% compared with a placebo over 18 months.
A panel of FDA advisers in early June unanimously voted in favor of Leqembi, saying clinical studies had verified its benefit, although several experts during the open public-hearing portion of the meeting raised concerns about safety issues identified in the clinical trials, including potential brain swelling or bleeding.
The drug’s label will have a boxed warning about amyloid-related imaging abnormalities, which usually have no symptoms but in some rare cases cause life-threatening brain swelling, the FDA said Thursday.
Alzheimer’s drug Leqembi receives accolades
Leqembi’s approval has received accolades from many scientists, doctors, and researchers in the field. Yet there are those who have approached the news with more hesitancy.
“I’m of the side that it’s not perfect, but it’s a step in the right direction,” Joy Snider, a neurologist and the head of Washington University’s School of Medicine in St. Louis, stated according to the journal Science.
Maria Carrillo, chief science officer of the Alzheimer’s Association and a neuroscientist in San Francisco, also agreed that Lecanemab was “a win for all of us.”
There are those against it, however, such as neurologist Alberto Espay of the University of Cincinnati.
“I think that this drug should not be approved,” Espay said in an interview prior to the FDA’s announcement of the drug’s approval.
But the officials at the agency “are victims of an artificially low bar” that he believes was set in 2021 for the drug aducanumab, another medication designed to treat Alzheimer’s.