The US Food and Drug Administration (FDA) has approved a new Alzheimer’s disease drug that can slow the progression of the disease.It’s ok For the drug Aducanumab From the pharmaceutical company Biogen. There is a lot of discussion about this drug, because it is very questionable whether it really works. The drug will be sold under the name Aduhelm.
In 2019, Biogen stopped research on the drug itself because it concluded that the drug had no effect. After further analysis of the results of the subgroups participating in the study, it was decided to apply for approval of the drug anyway. Critics pointed out at the time that the smaller the analyzed group, the greater the chance of coincidence if you observe the effect in that group.
In Alzheimer’s patients, aging brain cells are not broken down properly. This releases an accumulated toxic protein: beta-amyloid. According to the FDA, there is “a lot of evidence that Aduhelm reduces the accumulation of β-amyloid in the brain, and this reduction in accumulation has the potential to provide significant benefits to patients.” The product is intended for use in the early stages of the disease. .
Treatment consists of monthly intravenous injections of medications. The study also found significant side effects, such as brain swelling and bleeding.
Europe is also considering
It has been 15 years since the last Alzheimer’s drug was approved. Whether it will also be used in the Netherlands remains to be seen. In October 2020, Biogen also applied for approval from the European Medicines Agency (EMA). If it is also approved in the EU, the National Institute of Health Care must still initiate a process to determine the reimbursement of the drug. The drug can be marketed here as early as the second half of 2022, Expected Alzheimer’s disease in the Netherlands.
The FDA has made it a condition for Biogen to continue research after obtaining approval. If the so-called Phase 4 study shows that the drug is not effective, the FDA can withdraw the approval.