Last June, a new Alzheimer’s drug developed was approved by the FDA. However, many experts emphasized that the drug should not be approved, it is not useful and it is very expensive. Now the European Union has announced that it does not approve the drug.
in the past months US Food and Drug Administration (FDA)Approving an Alzheimer’s drug for the first time in 18 years, made a sensation all over the world and increased the hope of patients. However, some time after this approval Aducanumab (Aduhelm) There were interesting developments regarding the drug named drug. Three scientists at the FDA resigned after the drug’s human clinical trials and approval, and the FDA’s approval decision was ‘one of the worst decisions ever made‘ he described.
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 too from the European Union A negative decision was made regarding the drug.
Drug not approved
In the statements made by the European Medicines Agency (EMA), the Alzheimer’s drug called Aducanumab not approved announced. 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.
EMA’s decision is that people with early-stage Alzheimer’s 3,000 It was given as a result of two experiments on humans. During the study, some of the patients were given low and high doses of the drug, and the other part was given placebo pills without active substance. Subsequently, the results showed that the drug was effective in early-stage Alzheimer’s patients. not effective In addition to its emergence, another frightening side effect was encountered. In brain scans of patients taking the drug, scientists bloating and bleeding He stated that they encountered with the drug and said that the drug could be harmful.
RELATED NEWS
World Health Organization Grants Emergency Use Approval for ‘Covovax’ Vaccine Made in India
In the news, the US-based manufacturer of the drug of biogen It was also stated that he 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.