A new drug for Alzheimer’s disease has been approved in the United States for the first time in 20 years. The drug would slow down not only the symptoms, but also the disease itself. However, according to experts, it is not a panacea. So what can we expect from it?
On June 7, the United States Food and Drug Administration (FDA) announced that the drug aducanumab is admitted to the US market as a treatment for Alzheimer’s disease. That statement is quite unexpected: an advisory committee had previously expressed a negative opinion about the drug, because there are doubts about its efficacy and safety.
Aducanumab works against the so-called amyloid beta protein, which builds up in the brains of people with Alzheimer’s dementia. That protein is associated with the development of the disease.
- Five years ago, research showed that aducanumab would slow down the symptoms of dementia. Follow-up research could not confirm this. That’s why it was discontinued.
- Still later, the manufacturer came with the news that additional data would show that the drug could still work. The latest data has not yet been published.
There are important caveats to what is known: high doses of aducanumab have been shown to slightly slow down the decline in a limited group of patients in an early stage of Alzheimer’s disease. On a scoresheet for symptoms of dementia, patients receiving aducanumab had a decline of approximately 1.38 points (on a scale of 0 to 18) after 1.5 years. Patients who received a placebo (dummy drug) had a decline of about 1.77 points. A small advantage of 0.39 points at 1.5 years may not even be noticeable in practice. There is a difference of at least 1 to 2 points required.
As many as 35% of patients experienced potentially serious side effects from the drug.
The drug must be given through an IV every month.
How should you interpret this news?
For decades, the search for effective medicines against dementia, and in particular against Alzheimer’s disease, the main cause of dementia, has been fruitless. Every news item about possible medicines immediately makes the world press.
The FDA has indicated that the manufacturer must conduct further research, even now that the drug has already been admitted to the American market: If the follow-up study shows that the efficacy is nevertheless disappointing or the side effects are too serious, the drug can be withdrawn from the market again. It also needs to become more clear about the practice and costs of the monthly day hospitalization to administer the drug.
The authorization of aducanumab on the US market is closely monitored in Europe. The medicine has not yet been approved by the European Medicines Agency (EMA) and is therefore not yet available on the European market. It will take at least another year before we have more clarity about the efficacy, safety and costs of aducanumab.
Conclusion
The new Alzheimer’s disease drug, approved for the US market, is not (yet) available in Europe. There are serious doubts as to whether this newcomer can really slow down the symptoms of dementia, which has not been sufficiently proven to date. At best, the disease is slowed down slightly in a limited group of patients who have been taking the drug for at least a year and a half. The news gives false hope to people and families with Alzheimer’s disease.
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On June 7, the U.S. Food and Drug Administration (FDA) announced that the drug aducanumab will be admitted to the U.S. market as a treatment for Alzheimer’s disease. That statement is quite unexpected: an advisory committee had previously expressed a negative opinion about the drug, because there are doubts about its efficacy and safety. Aducanumab works against the so-called amyloid beta protein, which accumulates in the brains of people with Alzheimer’s dementia. That protein is associated with the development of the disease. Important caveats should be noted about what is known: Aducanumab in high doses has been shown to slightly slow the decline in a limited group of patients in an early stage of Alzheimer’s disease. to slow down. On a scoresheet for symptoms of dementia, patients receiving aducanumab had a decline of approximately 1.38 points (on a scale of 0 to 18) after 1.5 years. Patients who received a placebo (dummy drug) had a decline of about 1.77 points. A small advantage of 0.39 points at 1.5 years may not even be noticeable in practice. This requires a difference of at least 1 to 2 points. As many as 35% of patients experienced potentially serious side effects from the drug. The drug must be given through an IV every month. How should you interpret this news? For decades, the search for effective medicines against dementia, and in particular against Alzheimer’s disease, the main cause of dementia, has been fruitless. Every news item about possible drugs immediately makes the world press. The FDA has indicated that the manufacturer must conduct further research, even now that the drug has already been admitted to the American market: If the follow-up research shows that the efficacy is nevertheless disappointing or the side effects are too serious , then the drug can be taken off the market again. More clarity is also needed about the practice and costs of the monthly day hospitalization to administer the drug. The authorization of aducanumab on the American market is closely followed in Europe. The medicine has not yet been approved by the European Medicines Agency (EMA) and is therefore not yet available on the European market. It will be at least another year before we have more clarity about the efficacy, safety and costs of aducanumab. Read more on Health and Science
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