A novel Alzheimer’s treatment received final clearance from the US drug authority this week, making it more readily accessible to the public through government-run senior health insurance.
Leqembi, a drug co-developed by the American pharmaceutical company Biogen and the Japanese company Eisai, was demonstrated in a clinical trial to very slightly slow cognitive deterioration in people with early-stage Alzheimer’s disease.
The research did, however, raise questions about adverse consequences such as brain swelling and bleeding.
Leqembi was first given “accelerated approval” by the Food and Drug Administration in January, meaning it wasn’t generally covered by the Medicare program administered by the government for those over 65.
Following more research on the medicine, a decision was made this week that would result in Medicare covering a sizable amount of the therapy, which the drug’s manufacturers had first estimated would cost $26,500 per year.
“This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease,” said senior FDA official Teresa Buracchio in a statement.
“This is welcome news for the millions of people in this country and their families who are affected by this debilitating disease,” added Chiquita Brooks-LaSure, head of the organization that oversees Medicare.
Medicare beneficiaries, however, will still be responsible for covering 20% of the cost, or thousands of dollars, on their own.
Alzheimer’s, which is characterized by memory loss and deteriorating mental sharpness, affects about 6.5 million people in the United States.
Leqembi, also known as lecanemab, is an antibody therapy that is injected into the brain every two weeks and reduces amyloid beta, a protein that develops into plaques and results in the death of brain cells as well as brain atrophy.
Patient advocacy organizations praised the FDA’s decision.
“This treatment, while not a cure, can give people in the early stages of Alzheimer’s more time to maintain their independence and do the things they love,” said Joanne Pike, president and CEO of the Alzheimer’s Association.
“This gives people more months to enjoy celebrating their significant others, kids, and grandchildren.”
The second medication for Alzheimer’s developed by Eisai and Biogen to get approval was called Leqembi. The first, Aduhelm, was authorized in 2021, although the decision was extremely debatable due to the contradictory effectiveness evidence.
In May, US pharmaceutical company Eli Lilly revealed that their medicine donanemab also markedly reduced cognitive loss related to Alzheimer’s disease and will shortly seek global regulatory clearance.
According to the Alzheimer’s Association, Alzheimer’s disease causes 60 to 80 percent of dementia cases.It gradually impairs thinking and memory until people are unable to do even the most basic activities.