Jun 09, 2021 16:00:00

Researchers criticize the regulatory-approved 'Alzheimer's drug', 'the risk of brain swelling is very high.'

Regarding Eisai 's Alzheimer's disease treatment drug ' ADUHELM ' newly approved by the US Food and Drug Administration (FDA), which has jurisdiction over domestic drug regulations, researchers and others said that 'there is a 40% risk of brain swelling' and 'effectiveness'. It has not been confirmed. '

A “disgraceful decision:” Researchers blast FDA for approving Alzheimer's drug | Ars Technica
https://arstechnica.com/science/2021/06/a-disgraceful-decision-researchers-blast-fda-for-approving-alzheimers-drug/

On June 8, 2021, 'Aducanumab (trade name: ADUHELM)' jointly developed by Japanese pharmaceutical giant Eisai and America's oldest pharmaceutical manufacturer Biogen received FDA approval. ADUHELM is a drug that acts on Alzheimer's disease by reducing amyloid β plaque, which is known to be abundant in the brain of Alzheimer's disease patients. Haruo Naito, CEO of Eisai, commented, 'We are very pleased to open a new page in the history of Alzheimer's disease treatment.'

FDA Approves Alzheimer's Disease Treatment Developed by Japanese Company-GIGAZINE

However, researchers and others have criticized the approval of ADUHELM. These criticisms are concentrated on two points: 'problematic clinical trial data' and 'questionable statistical evaluation.'

'Problem clinical trial data' is for two randomized, double-blind, placebo-controlled phase III trials conducted in 2019, with the conclusion that the trials conducted in the first half were 'ineffective' by Biogen. It is questioned how the test was terminated early by. According to news site Ars Technica, Biogen retested in the second half of the year after the first test failed, claiming a slight benefit. When the dose was increased from the first study, the results were 'a slight decrease in amyloid β plaque over 78 weeks' and 'a slight improvement in the cognitive function test', but at the same time, 'subjects' Brain swelling was confirmed in about 40%. '

In this regard, Eisai said, 'ADUHELM can cause serious side effects such as: Amyloid-related imaging abnormalities (ARIA) are common side effects that usually do not cause symptoms. It may be serious. '

Regarding the 'questionable statistical assessment,' an FDA reviewer said in November 2020, 'Biogen's analysis is unfounded and convincing and substantive evidence of its therapeutic and slowing effects. Not only did they publish statistical assessments that 'no' and 'another study is awaited to reach a definitive conclusion,' but up to 10 of the 11 members of the FDA's independent peer review committee said 'Biogen's. The problem was that they voted 'No' to the question 'whether to consider the submitted data as primary evidence that aducanumab is valid.' In addition, the remaining one member voted for the option to forgo the conclusion that it is 'uncertain'.

As mentioned above, the FDA had made a negative conclusion to ADUHELM as of November 2020, but suddenly changed its opinion and issued this approval. 'There is no clear vision of a concrete benefit for people with dementia, which is a dangerous precedent,' said Mark Dallas, a neuroscientist at the University of Reading. 'It could upset meaningful dementia treatment research,' said Robert Howard of College London, and 'shameful,' said Derek Rowe, a pharmaceutical industry expert who is also a columnist at the Royal Society of Sciences. doing.