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Alzheimer’s Disease
Context:
Donanemab, a new therapy for Alzheimer’s disease developed by drug maker Eli Lilly, has received unanimous support from independent scientists advising the United States Food and Drug Administration (USFDA), bringing it a step closer to clinical use.
More on news:
- The FDA advisory committee stated in a briefing document that the potential risks of donanemab,
- when appropriately managed according to labelling instructions, are outweighed by the demonstrated benefits on clinical endpoints in individuals with Alzheimer’s disease (AD).
- There were few reason to delay in approval,
- Therapy was stopped in patients who achieved a specific level of amyloid beta plaque clearance.
- Additional scrutiny followed a US congressional committee’s investigation into the approval process of aducanumab, revealing irregularities.
- Approval was given despite clinical trial cancellation and an expert panel’s recommendation against it.
Donanimhaber Overview and Mechanism of Action:
- It is a monoclonal antibody targeting amyloid beta protein depositions in the brain, a key feature of Alzheimer’s disease.
- Phase 3 study: Slows cognitive decline by 35.1% over 76 weeks.
- Main adverse effects: Brain swelling (24% of participants) and brain bleeds (19.7% of participants), mostly asymptomatic.
- Benefits:
-
- Designed for early-stage Alzheimer’s disease patients, specifically those with mild cognitive impairment or mild dementia.
- Shows significant and clinically meaningful slowing of disease progression.
- Function Retention: Patients on the drug retain their cognitive and functional abilities for a longer period.
- Risks:
-
- Adverse Effects: Includes amyloid-related imaging abnormalities (ARIA) such as brain bleeds and seizures, Most ARIA events were non-serious.
- ARIA events typically resolved or stabilised after discontinuation of therapy.
Importance of the Breakthrough:
About Alzheimer’s disease:
- It is a brain disorder that gets worse over time.
- It’s characterised by changes in the brain that lead to deposits of certain proteins.
- It causes the brain to shrink and brain cells to eventually die.
- It is the most common cause of dementia — a gradual decline in memory, thinking, behaviour and social skills.
- These changes affect a person’s ability to function.
- The causes probably include a combination of age-related changes in the brain, along with genetic, environmental, and lifestyle factors.
- In most people with Alzheimer’s, symptoms first appear later in life.
- Dementia: It is a syndrome that can be caused by a number of diseases which over time destroy nerve cells and damage the brain, typically leading to deterioration in cognitive function
- Alzheimer disease is the most common form of dementia and may contribute to 60–70% of cases.
- Dementia ranges in severity from the mildest stage,
- when it is just beginning to affect a person’s functioning,
- to the most severe stage, when the person must depend completely on others for help with basic activities of daily living.