Monday, June 7th, 2021
Effectiveness is highly controversial
US authorities approve drugs against Alzheimer’s
A number of pharmaceutical companies have already failed to develop an effective drug against Alzheimer’s. The company Biogen may now have achieved the breakthrough, the FDA approves the preparation in the USA. However, the effectiveness is highly controversial.
Despite controversial effectiveness, the US FDA approved a new Alzheimer’s drug. The active ingredient aducanumab is the first novel treatment method against the neurodegenerative disease that has been approved since 2003, said the FDA. The drug developed by the US biotechnology group Biogen is intended to be given to patients with early Alzheimer’s disease as a monthly infusion and to stop the decline in mental power.
Aducanumab is a so-called monoclonal antibody from Biogen. These are directed against proteins – called beta-amyloids – which in Alzheimer’s disease are increasingly deposited between the brain cells and form plaques. As a result, among other things, the connections between the nerve cells are disturbed and interrupted, the nerve cells die – forgetting sets in.
How well aducanumab works, however, is controversial: In 2015, the pharmaceutical company began with two studies, two years later, in cooperation with the Japanese pharmaceutical company Eisai, tests were carried out for the market launch. In 2019, both studies entered phase III. canceled due to a lack of prospect of success. An internal advisory committee of the FDA had spoken out against the approval. Shortly afterwards, the company published further evaluations, which have now confirmed effectiveness – at high doses and in patients at a very early stage of detection.
Brain swelling in every third patient
Controversy arose over the conflicting results. In addition to the rather low effectiveness, side effects worried the scientists. When higher doses were given, every third patient developed a swelling of the brain, which, however, regressed again after the therapy was discontinued. However, some scientists stressed that with such low effectiveness, the risks are very great. The follow-up costs are also very high, since the patients have to be continuously monitored with imaging. The doubts also existed within the FDA, but in the end they decided in favor of approval.
“We are very aware of the attention surrounding this approval,” said the FDA. It was concluded that the benefits of aducanumab outweigh the risks. The active ingredient will now be closely monitored, and the manufacturer will have to carry out further studies. “If the active ingredient doesn’t work as intended, we can take steps to get it off the market.”
The drug is not approved in Germany, but the pharmaceutical company submitted an application for approval to the European Medicines Agency (EMA) last year. A decision could be made this year.