Alzheimer’s drug Leqembi gets full FDA approval


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While here in Japan, we wait. The drug is currently undergoing priority review by Japan’s Pharmaceuticals and Medical Devices Agency, which means it won’t be approved in Japan until this fall at the earliest.

According to an article in the Japan Times, “even if the drug is approved in Japan, a number of hurdles would need to be cleared before it reaches patients, such as increasing the number of specialist doctors and establishing a patient screening and follow-up system. Financial concerns are also an issue for both patients and the government.”

Additionally, the drug is only mildly effective. According to that Japan Times article:

The drug’s efficacy was shown in an international clinical trial that involved 1,795 participants with early-stage Alzheimer’s, with the results published last November. Lecanemab slowed cognitive decline by 27% after 18 months of treatment compared with those given a placebo.

This translates to a delay in the progress of the disease by five to 7½ months within 18 to 24 months after the start of treatment, according to the researchers. Another study simulates that it could delay the progression from mild cognitive impairment (MCI) to mild Alzheimer’s by 2½ years and to moderate Alzheimer’s by 3.1 years.

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The decision is not free from criticism about the justification of letting a drug with so limited benefits consume resources after it is included in insurance schemes, but patients are understandably desperate to get their hands on anything that could decrease the speed in which they lose their mental capabilities.

Hopefully we will see in the near future if this decision was or not correct, since it puts in a balance risks and benefits of one single kind of patient against the rest of them a mistake could be very costly and may even end up with deaths attributed to it.

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The FDA confirmed those results by reviewing data from a larger, 1,800-patient study in which the drug slowed memory and thinking decline by about five months in those who got the treatment, compared to those who got a dummy drug.

Great work by the FDA, which has legal authority, and has been backing many medicines in the news recently.

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Great work by the FDA, which has legal authority, and has been backing many medicines in the news recently.

Approving something that already has been fully developed and tested as effective and safe do not means it is being backed by the FDA, it just means it is not arbitrarily rejected.

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