After nearly a decade of collaboration between Japanese pharmaceutical company Eisai and US-based Biogen, a significant breakthrough has finally emerged in the field of Alzheimer’s research. The US Food and Drug Administration (FDA) has granted its approval for Leqembi, an intravenous medication that effectively slows down the progression of Alzheimer’s disease.
Initially, Leqembi received preliminary approval in January with limited usage authorization. However, this approval was contingent upon the completion of a confirmatory study by the two drug manufacturers to validate the drug’s clinical benefits.
It is important to note that while Leqembi can slow the progression of Alzheimer’s, it is not a cure. Instead, it targets the underlying biological mechanisms that contribute to the advancement of the disease. By reducing the formation of amyloid plaques, which are abnormal protein aggregates in the brains of Alzheimer’s patients, Leqembi addresses a key aspect of the condition.
Leqembi is not the only drug designed to target beta-amyloid plaque accumulation in Alzheimer’s treatment. Aduhelm, approved through the same accelerated pathway in 2021, is still awaiting full FDA approval. However, what sets Leqembi apart from its predecessor is its demonstrated clinical benefits beyond merely reducing the buildup of these proteins.
The administration of Leqembi necessitates professional oversight and must be performed in a hospital or infusion center every two weeks. Acknowledging the need for improved accessibility, Biogen CEO Christopher Viehbacher has emphasized the company’s commitment to collaborating with Eisai to make Leqembi available to eligible patients as soon as possible.
Unfortunately, the high cost of the drug, priced at $26,500, will pose a significant barrier to access for most individuals. Current regulations suggest that it is unlikely to be covered by Medicare. The Alzheimer’s Association states that Medicaid recipients may be eligible for coverage in most cases, but patients would still be responsible for a 20 percent copay amounting to approximately $5,300. Experts estimate that the total annual cost of Leqembi treatment, considering infusions and laboratory tests, could exceed $90,000.
The expensive nature of this treatment program is a concerning factor for the one in nine Americans over the age of 65 who are affected by Alzheimer’s dementia. As the country’s aging population continues to grow, this number is projected to increase significantly, with the population of Americans aged 65 and older expected to rise from 58 million in 2021 to 88 million by 2050. Consequently, there is a growing emphasis on the development of treatments and diagnostics for Alzheimer’s, including blood tests that can detect the disease.
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Frequently Asked Questions (FAQs) about Alzheimer’s treatment
What is Leqembi?
Leqembi is a drug that has received FDA approval for the treatment of Alzheimer’s disease. It is the first medication known to slow down the progression of the disease.
How does Leqembi work?
Leqembi works by reducing the formation of amyloid plaques, which are abnormal protein aggregates in the brains of individuals with Alzheimer’s disease. By targeting this underlying biological mechanism, Leqembi addresses one of the key factors contributing to the advancement of the disease.
Is Leqembi a cure for Alzheimer’s?
No, Leqembi is not a cure for Alzheimer’s. While it can slow down the progression of the disease, it does not eliminate it entirely. Leqembi addresses the underlying biology that drives Alzheimer’s advancement but does not provide a complete solution.
How often is Leqembi administered?
Leqembi requires professional administration in a hospital or infusion center every two weeks. It is not a medication that can be taken independently at home.
What are the challenges with Leqembi’s accessibility?
One major challenge is the high cost of Leqembi, which makes it inaccessible to many individuals. The drug’s price tag of $26,500 and the potential lack of Medicare coverage pose financial barriers to access. Medicaid recipients may have some coverage, but they would still be responsible for a significant copay amount.
How common is Alzheimer’s disease?
Alzheimer’s disease affects approximately one in nine Americans over the age of 65. With the aging population expected to grow significantly, the number of individuals with Alzheimer’s is projected to increase from 58 million in 2021 to 88 million by 2050.
Are there alternative treatments for Alzheimer’s?
Leqembi is not the only drug targeting the beta-amyloid plaque buildup associated with Alzheimer’s. Aduhelm is another medication that received approval but is still awaiting full FDA approval. However, Leqembi stands out as it has demonstrated clinical benefits beyond reducing the accumulation of these proteins. Other treatments and diagnostics, such as blood tests, are also being developed to detect and manage Alzheimer’s disease.