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FDA approves first drug slowing Alzheimer's

July 8, 2023
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Leqembi, a new Alzheimer's drug developed jointly by Eisai and Biogen, has received FDA approval for intravenous use, becoming the first approved treatment that can slow the disease's progression. However, the drug is costly and requires professional administration.

Decade-long Collaboration: Eisai and Biogen have been collaborating for about ten years on Alzheimer's research.
  • Leqembi, their joint development, recently received FDA approval for intravenous use.
  • This approval marks the first treatment that can slow Alzheimer's progression.

  • Drug's Function and Approval: Although Leqembi is not a cure, it addresses the underlying biology of Alzheimer's.
  • Leqembi reduces amyloid plaques, or misfolded proteins in the brain, associated with Alzheimer's disease.
  • The drug received preliminary approval in January, conditional on further confirmatory studies to prove its clinical benefit.

  • Comparison to Other Treatments: Leqembi isn't the only drug targeting beta-amyloid plaque buildup in Alzheimer's treatment.
  • Aduhelm, another similar drug, was approved under an accelerated pathway in 2021 but isn't fully FDA-approved.
  • Unlike Aduhelm, Leqembi has demonstrated actual clinical benefit in addition to reducing protein buildup.

  • Administration and Accessibility: Leqembi's administration and accessibility pose challenges.
  • The drug requires professional administration in a hospital or infusion center every two weeks.
  • Christopher Viehbacher, the CEO of Biogen, highlighted the importance of working with Eisai to make Leqembi accessible to eligible patients as soon as possible.

  • Cost Considerations: The high price of Leqembi limits its accessibility.
  • The drug's annual cost is $26,500, which is unlikely to be covered by Medicare.
  • For Medicaid recipients, the drug might be covered but patients would still be responsible for a 20% copay, around $5,300.
  • Total treatment costs, including infusions and lab tests, can exceed $90,000 per year.

  • Demographic Factors: The demand for Alzheimer's treatments is likely to increase due to an aging population.
  • One in nine Americans over the age of 65 have Alzheimer's dementia.
  • The number of Americans 65 and older is projected to increase from 58 million in 2021 to 88 million by 2050, which will likely intensify the focus on Alzheimer's diagnostics and treatments.

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