I previously wrote about this on my blog, but, on July 6, finally, Leqembi which targets amyloid beta, a new drug for Alzheimer's disease developed by Eisai in Japan and Biogen in the United States, was given full approval by the U.S. Food and Drug Administration. The results of clinical trials in the later stage showed that the decline in cognitive function of participants was slowed down by 27% over a period of 18 months. This is estimated that it is equivalent to delaying the progress for four to five months. This delay can be significant and can mean the world to people living with Alzheimer’s and their families. Leqembi is intended and designed for people with mild cognitive impairment or early Alzheimer's, and it is not meant for those embodying advanced symptoms. In the United States, by receiving full approval, the cost of this treatment will be covered by Medicare as long as the providers who prescribe the drug participate in registries to collect evidence. As I mentioned last time, the annual cost is $26,500. 80% is covered by Medicare, which means 20% will be at one’s own expense. In addition, to qualify, first of all, one has to do an expensive PET scan or lumbar punctures that may also put a strain on one’s body. These procedures are necessary in order to confirm there is an accumulation of amyloid beta in the brain. Thus, some economic burden on those who use Leqembi is expected. In addition, this medicine is administered intravenously every other week. Depending on where the treatment is carried out, it can be difficult and a real challenge for some people to go to the hospital twice a month. Currently, clinical trials of self-administration (injection in the thigh) are also underway, so hopefully, in the end, self-injection can solve such a potential problem. We certainly need more time to determine if this Leqembi is a breakthrough or another possible medical/systemic disappointment. In my home country, Japan, it is expected that the results of whether or not to approve Leqembi will be given this fall. I will closely monitor this matter and promise to keep my readers posted on its progress!
If you are interested in, here's the press release from Eisai.
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