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A new drug against Alzheimer’s disease will be approved in the United States, the US Food and Drug Administration (FDA) said in a statement on Monday.
U.S. regulators announced Monday that they would approve a new drug for Alzheimer’s disease for the first time in nearly 20 years.
“This approval is significant in many ways,” the United States Food and Drug Administration (FDA) said in a statement. The drug, named Aduhelm and manufactured by the pharmaceutical company Biogen, is “the first approved treatment for Alzheimer’s disease since 2003,” the FDA said.
Better yet, she added, it is the first treatment for the “presence of beta-amyloid plaques in the brain” that causes the disease.
Quick procedure
In November, an expert committee ruled against approval, ruling that the treatment had not fully demonstrated its effectiveness. That is why the FDA has said it will use expedited procedures to only grant conditional authorizations for products that may not have been considered by the Commission.
“The FDA is asking Biogen to conduct post-approval clinical trials to validate the drug’s clinical benefits. If the drug does not work as expected, it may take steps to withdraw from the market. There are. ”
Almost 6 million Americans live with Alzheimer’s disease. Alzheimer’s disease, the sixth leading cause of death in the United States, is a disease whose research has stalled for decades.
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US approves new treatment for Alzheimer’s disease
Source link US approves new treatment for Alzheimer’s disease
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