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FDA Decision on Alzheimer’s Drug Leqembi Could Mark Turning Point

The FDA is poised to make a critical decision on granting traditional approval to Leqembi – the first drug to show promise in slowing Alzheimer’s disease. 

This could potentially alter and expand access to millions of patients with early-stage Alzheimer’s.

Leqembi: Awaiting FDA Approval for Alzheimer’s Treatment

As the US Food and Drug Administration (FDA) stands on the cusp of deciding the fate of Leqembi, an Alzheimer’s drug, the anticipation within the medical community and amongst patients is palpable. The drug, developed by Eisai and Biogen, has already garnered attention for its role in alleviating amyloid plaque buildups in the brain that are linked to Alzheimer’s.

Leqembi, initially granted accelerated approval in January, is now under consideration for traditional approval, which could substantially broaden its accessibility. The Centers for Medicare and Medicaid Services (CMS) had previously limited coverage, but a change in this stance could open doors for an estimated million patients with early Alzheimer’s.

Results of Leqembi Trial

Leqembi demonstrated a significant reduction in amyloid beta plaque, a key marker of the disease.

The clinical trial evaluated the drug in 856 patients with mild cognitive impairment or mild dementia, demonstrating dose-dependent and time-dependent effects. Over the course of the 18-month trial, it showed a 27% slowdown in declines of cognitive ability and function. However, it is important to note that the drug carries risks, including brain swelling or bleeding, which were experienced by approximately 13% of the trial participants. Factors such as genetics or the use of blood-thinning medications may further increase these risks.

Leqembi’s approval is based on its ability to reduce amyloid beta plaque, which is associated with Alzheimer’s disease. However, the drug comes with warnings for potential side effects, including amyloid-related imaging abnormalities (ARIA) and infusion-related reactions. These side effects typically resolve over time, but serious events are rare. The most common side effects of Leqembi include infusion-related reactions, headache, and ARIA.

Initiating Leqembi in patients with mild cognitive impairment or mild dementia, as studied in the clinical trials, is important to note. Currently, there is a lack of safety and effectiveness data for other stages of the disease. The approval of Leqembi instills hope for improved treatments for Alzheimer’s disease, although further research is necessary.

Understanding Alzheimer’s: A Glimpse into the Debilitating Disease

Alzheimer’s disease is a neurodegenerative disorder that primarily affects the elderly, leading to memory loss and a decline in cognitive functions. As the disease progresses, it severely impacts a person’s ability to perform daily activities. 

Researchers believe that factors such as genetics, ageing, and lifestyle play a role in Alzheimer’s disease, which is characterised by the accumulation of proteins in the brain. These proteins form plaques and tangles that interfere with communication between brain cells and ultimately cause cell death. However, the exact cause of Alzheimer’s is not yet fully understood.

Current Landscape of Alzheimer’s Treatment

Currently, the treatment of Alzheimer’s disease primarily focuses on managing symptoms rather than reversing or halting the progression of the disease. Healthcare providers often prescribe medications like cholinesterase inhibitors (e.g., Donepezil) and memantine to alleviate cognitive symptoms by improving communication between brain cells and regulating neurotransmitters that are essential for memory and learning.

However, these drugs often have limited effectiveness and vary from person to person.

In addition to medication, healthcare providers consider cognitive therapy, physical exercise, and maintaining a balanced diet crucial in managing symptoms associated with Alzheimer’s disease.

Caregivers and family members play a significant role in ensuring a safe and supportive environment for patients.

Key Takeaways

Leqembi represents a potentially revolutionary step in Alzheimer’s treatment,but it is essential to approach this development with caution and preparedness. It may give patients precious additional time with a higher quality of life.

Although the current treatments can provide relief to some extent, they do not offer a cure for Alzheimer’s. The FDA closely watches the possible approval of Leqembi due to the significance of the drug’s potential in addressing the underlying factors of Alzheimer’s disease.

While Leqembi is not a cure, it could represent a significant step forward in the treatment of this debilitating disease.

References:

1. What is Alzheimer’s? (n.d.). Alzheimer’s Disease and Dementia. https://alz.org/alzheimers-dementia/what-is-alzheimers

2. Alzheimer’s Disease Fact Sheet. (2023, April 5). National Institute on Aging. https://www.nia.nih.gov/health/alzheimers-disease-fact-sheet

3. Alzheimer’s disease – Diagnosis and treatment – Mayo Clinic. (2023, February 2). Alzheimer’s Disease – Diagnosis and Treatment – Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/alzheimers-disease/diagnosis-treatment/drc-20350453

4. Cummings, J., Lee, G., Ritter, A., Sabbagh, M., & Zhong, K. (2020, January). Alzheimer’s disease drug development pipeline: 2020. Alzheimer’s & Dementia: Translational Research & Clinical Interventions, 6(1). https://doi.org/10.1002/trc2.12050

5. Risk reduction of cognitive decline and dementia: WHO guidelines. (2019, January 1). Risk Reduction of Cognitive Decline and Dementia: WHO Guidelines. https://www.who.int/publications/i/item/risk-reduction-of-cognitive-decline-and-dementia

6. FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment. (2023, January 6). FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment | FDA. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment

7. Lecanemab Approved for Treatment of Early Alzheimer’s Disease. (n.d.). Alzheimer’s Disease and Dementia. https://alz.org/alzheimers-dementia/treatments/lecanemab-leqembi

8. Leqembi | ALZFORUM. (2017, December 29). Leqembi | ALZFORUM. https://www.alzforum.org/therapeutics/leqembi#:~:text=This%20trial%20enrolled%20856%20people,a%20positive%20amyloid%20PET%20scan.

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