The US FDA quickly approved a new drug for the treatment of Alzheimer’s disease, but the Food and Drug Administration reminded that its clinical efficacy still needs more evidence to support, and there are still safety concerns; the picture shows a situational photo. (Picture taken from freepik)
[Health Channel/Comprehensive Report]Alzheimer’s disease can be said to be a disease of modern civilization. This disease has always been considered an irreversible neurodegenerative disease, but on June 7 last year, the US Food and Drug Administration accelerated its approval. A new drug has been approved, which is the first new drug Aduhelm® (aducanumab) for the treatment of Alzheimer’s disease in nearly 20 years. However, the Food and Drug Administration reminded that the drug may have safety concerns at present, and clinical efficacy still needs more Evidence to support.
Food and Drug Administration on Facebookpharmacist zheng yao says“The article shared that past drugs for Alzheimer’s disease include acetylcholinesterase inhibitors and glutamate NMDA receptor antagonists (NMDA antagonists) that can slow down the rate of degeneration, but cannot. Address the underlying causes of Alzheimer’s disease.
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Recent studies have found that the cause of Alzheimer’s disease is related to beta-amyloid and tau proteins. So scientists are thinking that if you can clear the amyloid beta that builds up in the brain, it may be able to stop neurodegeneration. And the first phase of the clinical trial also yielded encouraging results that beta-amyloid did decrease with increasing doses of the drug. Therefore, scientists are in full swing to launch two large Phase III clinical trials.
However, the results of the third phase of the clinical trial were dismal. During the preliminary review of the data in half of the trial, the hosting team determined that the preliminary results were not sufficient to continue the trial, so it was terminated early.
But seven months later, the original manufacturer filed an NDA, citing a 22 percent reduction in the rate of neurodegeneration relative to a placebo in the high-dose arm of one of the trials. Although the majority of the committee members during the review process felt that the current evidence was insufficient to support the drug’s effectiveness, the FDA approved Aduhelm® (aducanumab ).
The Food and Drug Administration believes that in addition to novelty, clinical efficacy and safety are more important when a drug is marketed. The clinical efficacy of Aduhelm® (aducanumab) needs more evidence to support, in addition, the most worrying safety aspect is the potentially life-threatening brain inflammation symptoms. Currently, there are also more drugs that act to clear beta amyloid in clinical trials.
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