The US Food and Drug Administration has just approved a drug for Alzheimer’s disease for the first time in 20 years. Why do some people say it shouldn’t have been approved? Isn’t it safe?
The FDA has approved a new type of Alzheimer’s disease treatment that is thought to treat the underlying disease rather than the symptoms of Alzheimer’s disease. In November, an independent committee requested the FDA to reject the drug because the results of two identical Phase 3 trials were mixed. One showed no benefit and the other showed that it worked at higher doses.
The drug, sold under the name Aduhelm, may not be available to patients for at least 6 months. It is a monthly infusion, and there are concerns about whether it can be covered by insurance and how much it will cost.
The Cleveland Clinic was part of a clinical trial test of the drug and found some promises in it.
“It slowed the process,” said Dr. Babaktusi of the Cleveland Clinic. “Yes, because we don’t cure the illness or go back in time, it will be a good medicine for people in the early stages of the illness.”
This drug removes amyloid plaques in the brain. This is a substance that is believed to lead to amnesia. The debate is whether the drug also improves cognitive ability.
Supporters admit that the study isn’t perfect, but it may be useful for some rapid studies.
“This opens the door to a whole new way of treating and dealing with Alzheimer’s disease. Hopefully it will be one of the first to come in for many, if approved.” Tousi said.
It will also change the way Alzheimer’s disease is diagnosed. Because in order to get the drug, there must be evidence of amyloid plaques in the brain. But even if it is not approved, hope is not lost.
“There are three or four more in the pipeline, and in reality we get more promising results,” says Tousi.
Monica Robins is a Senior Health Correspondent at 3News. The information in this column is for educational and informative purposes only. If you have any questions about your medical condition or treatment, be sure to seek advice from your doctor or other qualified healthcare provider before starting a new medical regimen. Do not ignore professional medical advice or delay seeking it for some reason. Please read this column or on our website.
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Are Recently Approved Alzheimer’s Disease Drugs Safe? | Monica Medical Michelgas
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