The U.S. Food and Drug Administration just approved the first Alzheimer’s drug in 20 years. Why are some saying it shouldn’t have been approved? Is it not safe?
The FDA approved a new type of Alzheimer’s disease medication that is believed to treat the underlying disease rather than the symptoms of Alzheimer’s. In November, an independent panel urged the FDA to reject the drug because findings of two identical phase three trials were mixed. One showed no benefit, the other showed it worked at higher dose.
The drug – sold under the name Aduhelm – likely may not be available to patients for at least six months or more. It’s a once-a-month infusion drug and there’s concern about whether insurance will cover it and at what cost.
Cleveland Clinic was part of the clinical trial testing of the drug and found some promise to it.
“It slowed down the progression,” said Dr. Babak Tousi of Cleveland Clinic. “We do not cure the disease or turn back time, so yes it will be a good medication for people in earliest stage of disease.”
The drug removes amyloid plaque in the brain, a substance some believe leads to memory loss. The debate is whether the drug also improves cognitive ability.
Supporters admit the studies aren’t perfect, but it may help some and fast track research.
“This has opened the door to a whole new way of treating and addressing Alzheimer’s disease, and if it is approved it will be one of the first of many to come down the road hopefully,” Tousi said.
It would also change the way Alzheimer’s is diagnosed because in order to get the drug, there has to be evidence of amyloid plaque on the brain. But even if it doesn’t get approved, hope isn’t lost.
“We have three or four more in the pipeline that actually have more promising results,” Tousi said.
Monica Robins is the Senior Health Correspondent at 3News. The information provided in this column is for educational and informational purposes only. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen, and never disregard professional medical advice or delay in seeking it because of something you have read in this column or on our website.
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