On Friday, the Food and Drug Administration (FDA) approved a new drug called lecanemab, which will be marketed as Leqembi, for the treatment of Alzheimer's disease. The drug is an intravenous infusion that is administered every two weeks and is developed by Japanese pharmaceutical company Eisai. It is more promising than the other treatments that are currently available for Alzheimer's, but there are concerns about the safety of the drug.

Promising Results but Uncertainty Remains:

  • Studies of lecanemab suggest that it may modestly slow the pace of cognitive decline early in the disease, however, it also carries the risk of swelling and bleeding in the brain.
  • It is unclear from the medical evidence whether Leqembi could slow cognitive decline enough to be noticeable to patients. A recent report of findings from a large 18-month clinical trial, published in the New England Journal of Medicine and co-written by scientists from Eisai, concluded that "longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer's disease."

Partnership and Pricing:

  • Eisai is partnering with the US company Biogen, maker of the controversial Alzheimer's drug Aduhelm, for the commercialization and marketing of Leqembi.
  • The companies will split the profits equally. Eisai has announced that the list price for Leqembi will be $26,500 per year, which is slightly lower than Aduhelm's but higher than what some analysts have recommended.

Cost Effectiveness and Criticism:

  • Dr David Rind, the Chief Medical Officer for the Institute for Clinical and Economic Review, an independent nonprofit organization that assesses the value of medicines, said, �Based on our draft results, that price would not meet typical cost-effectiveness thresholds."
  • In a preliminary report last month, the institute said that to be cost-effective for patients, the price should be set between $8,500 and $20,600 a year.

Approval Controversy:

  • The FDA's approval of Leqembi comes after the agency faced criticism for approving Aduhelm, another Alzheimer's drug developed by Biogen, in 2021, despite a committee of independent advisers and an FDA council of senior officials stating that there was not enough evidence that it worked.
  • Last week, an 18-month investigation by two congressional committees found that the approval process for Aduhelm was �rife with irregularities� and involved an unusually close collaboration with Biogen. In response, the FDA said �the agency has already started implementing changes consistent with the committees� recommendations.�

Safety Measures:

  • In its decision, the FDA appeared to be acknowledging the criticisms it faced regarding Aduhelm by including narrower and more cautionary language on the Leqembi label. The label instructs doctors to only treat patients with early and mild stages of Alzheimer's disease, and not to treat patients without doing tests to confirm that they have one of the hallmarks of Alzheimer's: a buildup of the protein amyloid, which Leqembi (like Aduhelm) attacks.
  • The FDA also requested more data on subgroups of patients characterized by age, gender, health status, and other factors, and worked with the companies to include more diversity in the clinical trials.

Lecanemab, or Leqembi, has shown promising results in treating Alzheimer's disease, however, there are still concerns about the safety of the drug. The drug's high price point has also raised questions about its cost-effectiveness. Additionally, the approval of Leqembi comes after the FDA faced criticism for approving Adu helm, another Alzheimer's drug developed by Biogen, which raised concerns about the integrity of the approval process. Despite these issues, the drug's potential to slow cognitive decline in early-stage Alzheimer's patients, along with the lack of other effective treatments, makes it an important development in the fight against this devastating disease. However, it will be crucial for Eisai and Biogen to ensure that the drug is used appropriately and that its safety is closely monitored, and FDA to ensure the integrity of the approval process. As well, it's important to follow-up on the cost-effectiveness of the drug and its impact on affordability for the patient.


Written by IAS POINT

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