The US drug regulator gave full approval to a new Alzheimer’s drug on Thursday, in a move to make it widely available through government-run health insurance for the elderly.
Leqembi, which was jointly developed by Eisai of Japan and Biogen of the United States, was shown in a clinical trial to modestly reduce cognitive decline among patients in the early stages of the disease.
But the study also raised concerns about side effects, including brain bleeding and swelling.
Leqembi was initially granted “fast track approval” by the Food and Drug Administration in January, meaning it was not widely covered by the government-run Medicare program for people 65 and older.
Thursday’s decision, which came after further consideration of the drug, means Medicare will now bear a large portion of the treatment initially listed by the manufacturers at $26,500 annually.
“This confirmatory study demonstrates that it is a safe and effective treatment for Alzheimer’s patients,” said Teresa Boracchio, senior official at the US Food and Drug Administration, in a statement.
“This is welcome news for the millions of people in this country and their families affected by this debilitating disease,” said Chiquita Brooks Lashore, director of the agency that administers Medicare.
Leqembi, also known as lecanemab, is described as an antibody treatment injected into the brain every two weeks that works by reducing amyloid beta, a protein that builds up in plaques and causes brain cell death, as well as brain shrinkage.
Alzheimer’s Association President and CEO Joanne Pike said, “This treatment, while not a cure, can give people in the early stages of Alzheimer’s disease more time to maintain their independence and do the things they love.”
Leqembi was the second Alzheimer’s drug developed by Eisai and Biogen to gain approval, the first; Aduhelm was approved in 2021, but the decision was highly controversial because data on its effectiveness was inconsistent.
And in May, US drugmaker Eli Lilly announced that its drug donanemab significantly slowed cognitive decline associated with Alzheimer’s disease, and will soon seek approval from global regulators.