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An innovative Alzheimer’s treatment received final approval from the US drug authority on Thursday, making it more broadly accessible to the public through government-run health insurance for the elderly. Leqembi, a drug co-developed by Eisai of Japan and Biogen of the US, was demonstrated in a clinical trial to modestly slow cognitive deterioration in people with an early-stage illness.
However, the study also brought up issues with adverse effects such as brain swelling and bleeding.
Leqembi was initially given “accelerated approval” by the Food and Drug Administration in January, which meant it was not fully covered by the Medicare program, which is managed by the government and is available to anyone who is 65 years of age and older.
Following additional research on the medicine, a decision was made on Thursday that will result in Medicare covering a sizable percentage of treatment costs, which were initially estimated by the drug’s manufacturers to be $26,500 annually.
“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.
The head of the organization that oversees Medicare, Chiquita Brooks-LaSure, added: “This is good news for the millions of Americans and their families who are touched by this crippling illness.
However, Medicare beneficiaries will still be responsible for 20% of the cost, or thousands of dollars, on their own.
Alzheimer’s disease, which is prevalent in 6.5 million Americans and is marked by memory loss and deteriorating mental sharpness, is also known as dementia.
Leqembi, often referred to as lecanemab, is an antibody therapy that is injected into the brain once every two weeks. It reduces amyloid beta, a protein that forms plaques and kills brain cells, as well as brain shrinkage.
Patient advocacy organizations applauded 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 extends the number of months that people can celebrate their marriage, kids, and grandchildren.
The second Alzheimer’s medication created by Eisai and Biogen to get approval was called Leqembi. The first, Aduhelm, was approved in 2021, but the choice was highly contested because the efficacy findings were contradictory.
Donanemab, a medication from the US pharmaceutical company Eli Lilly, was announced as having a significant slowing effect on cognitive loss related to Alzheimer’s disease in May.
According to the Alzheimer’s Association, 60 to 80 percent of dementia cases are caused by Alzheimer’s disease. It gradually impairs thinking and memory, finally depriving individuals of the capacity to do even the most basic tasks.
Source- NDTV
