So that a new drug can be boughtin a pharmacy, it’s not enough to “just invent” it. You need to go through a lot of tests, tests and checks. And if we talk about medicines for diseases that are considered incurable (or difficult to treat), then control is strengthened several times. This happens with many drugs against Alzheimer's. And one of these drugs may soon become available. It remains to get approval from the US Food and Drug Administration (FDA). It is even more interesting that this medicine was previously recognized as ineffective, but new data indicate the opposite.
Is there a cure for Alzheimer's disease?
Clinical trials this MarchA biogen-based drug called Aducanumab was suspended due to low efficacy, but then Biogen reviewed its results and decided to apply for approval of the drug. According to the New Atlas publication, the action of aducanumab is 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 in animals, it has not yet proved its effectiveness for humans.
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However, in October Biogen announced thatthe earlier analysis was erroneous and subsequent data showed that aducanumab actually slows down cognitive decline in Alzheimer's disease. The discovered effect was so significant that the company decided to get FDA approval as soon as possible. A study of the effect of the drug over the next few months showed that patients receiving longer treatment with high doses of aducanumab showed significantly slower rates of development of cognitive impairment and a decrease in brain function compared to the control group.
The new drug was tested using the double test method.blind study (ed.: this is a study where neither doctors nor patients know which medicine is prescribed for a particular subject), but due to some discrepancies in the protocol, patients from the same group received different doses of aducanumab, ”explains Diego Gomez-Nicola, a researcher at the University of Southampton, who, as emphasized in New Atlas, has nothing to do with Biogen. In general, some patients received higher therapeutic doses and this led to a significant improvement in the condition. These results are extremely important for the industry, as they for the first time demonstrate the effectiveness of the treatment of Alzheimer's disease.
However, not all scientists are equally positive.refer to test data of aducanumab. Critics of the study suggest that in order to finally understand the effectiveness of the drug, Biogen must re-test the new drug. At the same time, the position of the FDA on this issue is still not completely clear. What do you think? Is it worth releasing such a medicine on the market? Write about it in our chat in Telegram.
It should be noted that in this casenot only the fate of the new drug depends on the decision of the FDA, but the whole direction in which the search for new drugs for the treatment of Alheimer's disease will go. After all, enormous bets have been made on adukanumab over the past few years. And if the FDA recognizes it as ineffective, then a lot of other similar studies will no one need. And much will have to, as they say, read from scratch.