Tuesday, September 14, 2021 (HealthDay News)
U.S. approval Alzheimer’s disease The drug aducanumab is already controversial.Now new research discovers most of it Alzheimer’s disease The patient would not have been able to participate Clinical trial That led to a green light.
In June, the US Food and Drug Administration granted accelerated approval to Aduhelm for the treatment of patients with mild cognitive impairment or mild cognitive impairment. dementia from Alzheimer’s disease disease.
The decision was quickly criticized due to the high price of biogen drugs ($ 56,000 per year) and the question of possible cooperation between regulators and pharmaceutical companies.
Now, this new study points out other limitations.
Phase 3 trials of this drug have shown an increased risk of certain adverse vascular events. The study excluded older patients, patients with certain chronic illnesses, and patients taking anticoagulants, but the FDA did not take precautions to treat the drug in these patient populations. Approved for use.
Dr. Timothy Anderson, an assistant professor at Beth Israel Deacoy Health in Boston, said:
“Public conversations about aducanumab have focused on limited benefits and high costs. The majority of patients Alzheimer’s disease The disease is likely to be at higher risk of adverse events than the patients studied in the trial, “Anderson said in a news release of the medical system.
In this study, researchers examined Medicare claims in 27 million patients with either cognitive (mental) disorders, Alzheimer’s disease, or Alzheimer’s disease-related disorders.
For example, the data show that about 9 out of 10 patients associated with Alzheimer’s disease dementia Or, Alzheimer’s disease itself had at least one factor to exclude from the trial. Similarly, 85% of patients with cognitive impairment had at least one disqualification.
And more than three-quarters of people associated with Alzheimer’s disease dementia There were some of these disqualified people, the researchers said.
“Aducanumab clinical trials studied relatively healthy participants who did not reflect the majority of older people. dementia “In the United States, as a result, Medicare should consider limiting the scope of aducanumab to patients who meet the eligibility criteria for the study,” Anderson said.
He said additional clinical trials of high-risk groups excluded from previous trials were needed and should include rigorous studies of adverse events.
The report was published on September 14th Journal of American Medical Association..
In July, two parliamentary commissions were reported to be investigating the processes leading to drug approval and its high costs. The FDA Advisory Board has concluded that there is not enough evidence to support the effectiveness of Aducanumab, but the FDA has approved it. After that, three of the members of the advisory board resigned.
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Source: Beth Israel Lahey Health, News Release, September 14, 2021
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Most Alzheimer’s patients would not have been eligible for a controversial drug trial: Study
Source link Most Alzheimer’s patients would not have been eligible for a controversial drug trial: Study