On Monday, June 7, the Food and Drug Administration (FDA) approved Aduhelm (aducanumab) for the treatment of Alzheimer’s disease, a condition that affects over 6 million people in the United States.1 The drug is a first-of-its kind therapy, according to the FDA.
“Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement.1
The drug is intended to slow the progression of Alzheimer’s disease. It is not a cure.
The news about Aduhelm’s approval is both exciting and controversial. It’s exciting because it is the first new drug approved to treat Alzheimer’s since 2003. It’s controversial because it’s not clear from the clinical trial that the drug will actually work. Last year, an FDA panel concluded there wasn’t enough evidence to prove the drug was effective.
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Source: Morning Consult