In order for a new drug can be buy in the drugstore, it is not enough to “just invent” it. You need to pass a lot of tests, tests and inspections. And if we talk about cures for diseases that are considered incurable (or difficult-to-treat), then control is amplified several times. So it is with many drugs against the disease of Alzheimer’s. And one of these drugs may soon become available. It remains to get approval from Management on control over foodstuff and medicines USA (FDA). The more interesting that this drug was previously found to be ineffective, but new data indicates otherwise.
A cure for Alzheimer’s disease exist?
In March of this year clinical trials of the drug based on the active substance called adekanola from the company Biogen has been suspended due to low efficiency, but then the company Biogen has revised its results and decided to apply for the production approval of the drug. As notes the edition New Atlas, action adekanmbi directed against the accumulation of amyloid plaques, which are considered the main cause of death of brain neurons in Alzheimer’s disease. Unfortunately, despite the successful experiments of this drug on animals, he never confirmed its effectiveness for people.
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However, in October, Biogen announced that the previous analysis was incorrect and the subsequent data showed that Eukanuba really slows down the decline of cognitive functions in Alzheimer’s disease. The effect was so significant that the company decided in no time to obtain FDA approval. Study of the effects of the drug in the next few months showed that patients receiving more prolonged treatment with high doses of Eukanuba, showed a significantly slower rate of development of cognitive impairment and decline in brain function compared with the control group.
The new drug was tested by the method of double-blind study (approx.red: this study, when neither the doctors nor the patients are not aware of what kind of medicine are assigned to one or another subject), but due to some differences in the Protocol of patients from one group received different doses of Eukanuba — explains Diego Gomez-Nicola, a researcher from the University of Southampton, who, as highlighted in the New Atlas, has no relationship to the company Biogen. In General, some patients received a higher therapeutic dose and this has led to a significant improvement. These findings are extremely important for the industry because for the first time demonstrate the efficacy of the treatment of Alzheimer’s disease.
However, not all scientists have the same positive attitude to the test Eukanuba. Critics of the study suggest that in order to completely understand the efficacy of the drug, Biogen needs to re-test a new drug. The FDA’s position on this issue is still unclear. What do you think? Is it worth to release such a drug on the market? Write about it in our chat in Telegram.
Not to mention the fact that in this case, the FDA decision depends not only the fate of a new drug, but in which direction will the search of new medicinal products for the treatment of diseases of Allgamer. After all, adekanola had made huge bets in the past few years. And if FDA finds him ineffective, then a lot of other such studies will become useless. And many will have to start with a clean slate.