FDA Approval for Donanemab A New Alzheimer’s Drug

GS Paper III Science and Technology

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.

Donanemab is a monoclonal antibody designed to remove toxic beta-amyloid plaques from the brains of people with early Alzheimer’s disease.

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.

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.

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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