In the past months, the US Food and Drug Administration (FDA) gave approval to an Alzheimer’s drug for the first time in 18 years, making an impact all over the world and increasing the hope of patients. However, after a while, there were interesting developments regarding the drug called Aducanumab (Aduhelm). Three scientists at the FDA resigned after the drug’s human clinical trials and approval, and described the FDA’s approval decision as “one of the worst decisions ever made.”
Apart from these three people, many scientists continued to view the drug negatively, stated that the cost of the drug was terribly high ($60 thousand) and recommended that it not be approved. A study we shared five months ago also supported these claims; It was revealed that the drug was sold for more than its value, had many side effects and did not provide any clinical benefit. Now, a negative decision has come from the European Union regarding the drug.
Drug not approved
In the statements made by the European Medicines Agency (EMA), it was announced that the Alzheimer’s drug called Aducanumab was not approved. The agency stated that this drug, which has caused great controversy in the last six months, is not effective in cases where Alzheimer’s symptoms are detected early. Many institutions working on Alzheimer’s reacted to this decision and stated that EMA had prevented the treatment of thousands of people.
The EMA’s decision was based on two experiments on 3,000 people with early-stage Alzheimer’s. During the study, some of the patients were given low and high doses of the drug, while the other part was given placebo pills without active substance. After that, the results examined revealed that the drug was not effective in early-stage Alzheimer’s patients, and another frightening side effect was found. Scientists stated that patients who took the drug encountered swelling and bleeding in brain scans and stated that the drug could be harmful.
It was also stated in the news that the US-based manufacturer of the drug, Biogen, could request a review of the decision. However, when we look at the studies and thoughts of scientists, we can say that it is very difficult for this drug, which was developed against Alzheimer’s, one of the most common diseases in the world, to get approval.
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