The American regulatory authority FDA has again approved a drug for Alzheimer’s. This could also be available in Europe in 2023. We answer the most important questions about the medication.
“Memory” is now played differently: Dementia is much more than just forgetfulness.
On Friday, the US FDA approved the drug lecanemab, which is said to help treat Alzheimer’s. The drug, made by the pharmaceutical companies Eisai and Biogen, is intended to slow the progression of the disease at an early stage.
In the last two years, three new drugs for Alzheimer’s dementia have caused a stir. It was a roller coaster of emotions for patients and their families. Approval applications have been granted, withdrawn or denied. Where are we now?
What are these substances?
The products bear the somewhat awkward names Aducanumab (developed by the companies Biogen and Neurimmune), Gantenerumab (Roche) and Lecanemab (Eisai and Biogen). All three contain antibodies as the active ingredient. These were created in the laboratory and all have the same goal: to bind to components of toxic protein clumps in the brain and dissolve them.
The hope is that the resolution will at least slow down the progression of the disease – ideally even stop it. It is known that thousands of such protein clumps form in the brain of Alzheimer’s patients and attach themselves to the nerve cells. As a result, the nerve cells perish. At some point there are too many holes in the brain so that it can no longer work properly. This then manifests itself in forgetfulness, personality changes and mental decline.
What do the substances do in the brain?
Both products from Biogen and its partners have been shown to reduce the amount of toxic clumps of protein in the brain. With the Roche drug, however, this was hardly the case in the clinical studies. It is still unclear whether this is due to the antibody itself. Or because not enough of it got into the brain. The Roche product is only injected under the skin, while the substance from Biogen is administered as an infusion directly into the bloodstream.
Do Alzheimer’s patients benefit?
Can’t say that yet. The first drug presented by Biogen called Aducanumab was not convincing in clinical studies. Only in the patients treated with a very high dose was a certain slowing down of the dementia observed in the observation period of less than two years.
According to the data presented in October 2022, the antibody called Lecanemab developed by Eisai and Biogen clinical study slow mental decline by 27 percent. So far, this also only applies to the observation period of 18 months. It is unknown how long the effect lasts.
However, it is currently not clear whether this slower progression of dementia has a noticeable impact on the everyday lives of those affected. Because a closer look at the details of the study shows that in areas such as memory, orientation skills or coping with household and personal hygiene, those treated performed only slightly better than the people in the placebo group after 18 months.
Can drugs cure Alzheimer’s?
no None of the antibodies could stop the decline in mental abilities. And it was certainly not possible to regain lost skills. But even a significant slowdown in mental decline would be of great help to those affected and their families. Because then everyday life would be easier and nicer, and for a longer time. Becoming demented less quickly can mean being able to consciously celebrate the golden wedding anniversary or the first grandchild.
Who should get the substances?
Patients at the beginning of Alzheimer’s disease, and the earlier the better, as experts emphasize. Because the fewer toxic protein clumps that have already formed, the less damage that has already occurred in the brain. The studies therefore primarily treated patients with mild Alzheimer’s disease.
It is completely unclear whether other dementia patients, for example those with vascular or frontotemporal dementia, could also benefit from the antibodies.
Do the remedies have side effects?
Yes. In the clinical studies, up to a fifth of those treated experienced minor bleeding and also swelling in the brain. However, most of these events were not even noticed by the treated patients and disappeared again. But since serious problems have occurred in rare cases, those treated must be monitored regularly. This also includes regular magnetic resonance imaging of the brain.
Two deaths after lecanemab administration are currently being investigated. It is still unclear whether the drug actually caused the cerebral hemorrhage. Fatal drug interactions may have occurred.
Where are the substances available?
Currently, none of the funds are freely available. In June 2021, contrary to the recommendations of its own advisory committee, the US regulatory authority FDA approved the Biogen antibody aducanumab (brand name Aduhelm). However, with the condition that further studies provide evidence of a real benefit for those treated. So far this has not been successful. In December 2021, however, the European approval authority EMA refused to approve aducanumab. In the spring of 2022, the manufacturer then withdrew the application for approval in Switzerland and also stopped marketing in the USA.
Following the FDA’s positive decision regarding lecanemab, Eisai and Biogen have announced that they will also apply for approval in Europe in the first quarter of 2023. Depending on how quickly the EMA decides, this antibody could be given to patients with mild cognitive deficits in the early stages of Alzheimer’s dementia in the EU as early as the second half of the year. It is expected that the companies will soon submit an application for approval to the Swiss regulatory authority, Swissmedic.