The FDA unanimously gave backing to Eli Lilly’s Alzheimer’s drug, Donanemab.
- The FDA confirmed that the drug has potential benefits for early-stage patients that outweigh the risks
Alzheimer’s Disease (AD)
It is a neurodegenerative disease that usually starts slowly and progressively worsens. It is a major cause of Dementia in patients.
- Symptoms: Memory loss, problems with language, disorientation etc.
- Duration: Long term.
- Prevalence: An estimated 5.3 million people are currently living with dementia in India.
- Alzheimer’s is one of the most common forms of dementia. This prevalence is likely to increase to 14 million by 2050.
- Risk factors: Genetics, head injuries, clinical depression, hypertension, psychological stress, lack of physical and mental exercise, Abnormal accumulation of amyloid-beta protein and tau protein inside neurons is also linked to the pathology of Alzheimer’s disease.
- Treatment: At present, there is no cure for Alzheimer’s disease. However, it can be managed by medicine and supportive therapies. These can temporarily reduce the symptoms.
- Amyloid beta_protein therapy: There are three main ways to target amyloid β-protein for treating Alzheimer disease: inhibiting its production, preventing its aggregation (or promoting its disaggregation), and promoting its clearance.
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About Donanemab Drug
Donanemab is a monoclonal antibody designed to remove toxic beta-amyloid plaques from the brains of people with early Alzheimer’s disease.
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- This drug is not the cure for Alzheimer’s; however, it is effective in lessening cognitive decline.
- It is the third drug after Leqembi and Biogento to show that removing amyloid early in the disease can slow neurological degeneration.
Benefits of Donanemab Drug
- Slows Cognitive Decline: The cognitive decline in early Alzheimer’s patients is slowed down by 35.1 per cent in 76 weeks.
- Improves patient’s Independence: It can extend patients’ ability to function independently by months and, possibly, years.
- Continued Benefits Post-Treatment: The drug’s benefits continued even after patients stopped taking the monthly infusions.
- Monthly Infusion Schedule: An infusion is required only once a month compared to other drugs.
Side Effects of Donanemab
- Safety Profile slightly risky: This may result in slightly higher adverse events than its predecessor, Lecanemab.
- Risk of ARIA: Risk of amyloid-related imaging abnormalities (ARIA) such as swelling or bleeding in the brain.
- Possibility of Treatment-related Deaths: Three treatment-related deaths were reported in the study.
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June 13, 2024