# Controversial Alzheimer’s drug not approved in EU
The European Medicines Agency (EMA) will not allow manufacturer Biogen’s new and controversial Alzheimer’s drug to enter the European market. The agency announced this today. The drug Aducanumab did enter the market in the United States earlier this year, causing considerable controversy.
Aducanumab cleans up a certain type of protein in the brain, which, according to the manufacturer, would slow down or even stop the disease. However, it has not yet been proven that the drug actually brings benefits to patients. In addition, according to the EMA the drug is not sufficiently safe. It can lead to bleeding and swelling of the brain. Therefore, the EMA judges that the benefits do not outweigh the risks and therefore it should not be allowed on the market.
The decision is in line with the opinion of many scientists worldwide. They say that although the drug removes the protein in question, studies by the drug manufacturer do not show any real effect in patients.
An independent scientific advisory committee to the EMA previously looked at Aducanumab. Dutch neurologist Edo Richard sits on that committee and responds approvingly to the EMA’s negative decision. “If you look at a drug and there is no effect, then you should not prescribe it. Patients are not clearly getting better from this drug. There is an assumption of an effect on a protein in the brain that should lead to less decline in thinking. But there is no scientific evidence for that.
“Some Dutch Alzheimer’s patients are being treated with the controversial drug as a trial. Neurologist Niels Prins of the Brain Research Centre company in Amsterdam is conducting these trials on behalf of Biogen. He is not surprised by the negative verdict of the EMA, but will continue with the tests. “In drug trials, safety is always an important consideration. Patients know that there can be side effects. They are informed about that in detail. You have to make a trade-off between positive effects and the side effects.”
**Billion-dollar project**
The Dutch associations of neurologists, psychiatrists and geriatricians said earlier that the chances are very small that doctors will prescribe the drug at all, and certainly not to large groups of patients. The drug is also being prescribed to patients in the United States much less than was expected. As a result, the billion dollar project of manufacturer Biogen could end up as a financial disaster. In a reaction, Biogen announced that it will appeal the EMA’s decision.
The American medicines authority FDA approved Aducanumab on condition that the manufacturer would continue to conduct research in the coming years to determine the effect of the medicine. This controversial decision was heavily criticized, also because of the high cost of the drug. Per patient, the drug costs about $56,000 per year. In total, there are about 300,000 people with Alzheimer’s disease in the Netherlands.
Good : it should never have been authorised in the US either. It basically has no effect, but it’s going to be prescribed for frightened and desperate people who have no alternative.
4 comments
A translation would be nice.
OP you need to provide translation
*Translation*
# Controversial Alzheimer’s drug not approved in EU
The European Medicines Agency (EMA) will not allow manufacturer Biogen’s new and controversial Alzheimer’s drug to enter the European market. The agency announced this today. The drug Aducanumab did enter the market in the United States earlier this year, causing considerable controversy.
Aducanumab cleans up a certain type of protein in the brain, which, according to the manufacturer, would slow down or even stop the disease. However, it has not yet been proven that the drug actually brings benefits to patients. In addition, according to the EMA the drug is not sufficiently safe. It can lead to bleeding and swelling of the brain. Therefore, the EMA judges that the benefits do not outweigh the risks and therefore it should not be allowed on the market.
The decision is in line with the opinion of many scientists worldwide. They say that although the drug removes the protein in question, studies by the drug manufacturer do not show any real effect in patients.
An independent scientific advisory committee to the EMA previously looked at Aducanumab. Dutch neurologist Edo Richard sits on that committee and responds approvingly to the EMA’s negative decision. “If you look at a drug and there is no effect, then you should not prescribe it. Patients are not clearly getting better from this drug. There is an assumption of an effect on a protein in the brain that should lead to less decline in thinking. But there is no scientific evidence for that.
“Some Dutch Alzheimer’s patients are being treated with the controversial drug as a trial. Neurologist Niels Prins of the Brain Research Centre company in Amsterdam is conducting these trials on behalf of Biogen. He is not surprised by the negative verdict of the EMA, but will continue with the tests. “In drug trials, safety is always an important consideration. Patients know that there can be side effects. They are informed about that in detail. You have to make a trade-off between positive effects and the side effects.”
**Billion-dollar project**
The Dutch associations of neurologists, psychiatrists and geriatricians said earlier that the chances are very small that doctors will prescribe the drug at all, and certainly not to large groups of patients. The drug is also being prescribed to patients in the United States much less than was expected. As a result, the billion dollar project of manufacturer Biogen could end up as a financial disaster. In a reaction, Biogen announced that it will appeal the EMA’s decision.
The American medicines authority FDA approved Aducanumab on condition that the manufacturer would continue to conduct research in the coming years to determine the effect of the medicine. This controversial decision was heavily criticized, also because of the high cost of the drug. Per patient, the drug costs about $56,000 per year. In total, there are about 300,000 people with Alzheimer’s disease in the Netherlands.
Good : it should never have been authorised in the US either. It basically has no effect, but it’s going to be prescribed for frightened and desperate people who have no alternative.
https://www.science.org/content/blog-post/aduhelm-so-far
Good write up on it here.