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12th June 2024 (12 Topics)

Donanemab, new Alzheimer’s drug

Context

The US Food and Drug Administration (FDA) has unanimously voted in favor of administering Donanemab, a new Alzheimer's drug.

What is Donanemab?

  • Donanemab is a monoclonal antibody, much like its predecessor Lecanemab, designed to target amyloid beta protein plaques in the brain, a characteristic feature of Alzheimer's disease that can be observed through imaging techniques.
  • Other amyloid-fighting drugs, such as Leqembi and Biogen, were approved by the FDA last year.
  • Donanemab can significantly slow down cognitive decline in early Alzheimer's patients by 35.1% over a span of 76 weeks.
  • It is currently the only one of its class available to Alzheimer’s patients, outside clinical trials.

Side Effects and Risks

  • Studies indicate that it may result in slightly higher adverse events compared to Lecanemab.
  • Apart from infusion-related reactions, the main concern lies in amyloid-related imaging abnormalities (ARIA), including brain swelling and bleeding.
  • The study revealed that 24% of participants experienced ARIA involving brain swelling, and 19.7% had ARIA involving brain bleeds. However, it's worth noting that most of these cases were asymptomatic.

Fact Box: Alzheimer's Disease

  • Alzheimer's disease is a progressive neurological disorder characterized by the degeneration and eventual death of brain cells. This degeneration leads to a range of symptoms, including:
  • Symptoms:
    • Memory loss
    • Difficulty with language (speaking or writing)
    • Impaired judgment
    • Changes in mood and personality
    • Confusion regarding time or place
    • Progression and Severity
  • The disease is believed to be caused by the abnormal accumulation of proteins in and around brain cells. Two key proteins involved in Alzheimer's pathology are:
    • Amyloid: Abnormal deposits of amyloid protein form plaques around brain cells.
    • Tau: Tangled formations of tau protein disrupt neuronal communication in the brain.
  • Dementia in India report 2020 estimates that there are 5.3 million people over the age of 60 years living with dementia in India, with the prevalence projected to increase to 14 million by 2050.

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