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SILVER SPRING, MARYLAND, June 8, 2021 ~ Monday, the Food and Drug Administration granted an accelerated approval for the Alzheimer’s treatment Aduhelm.
Aduhelm represents a first-of-its-kind treatment approved for Alzheimer’s, as well as the first new treatment for Alzheimer’s since 2003.
Alzheimer’s is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually, the ability to carry out simple tasks. These changes affect a person’s ability to remember and think. The specific causes of Alzheimer’s are not fully known.
“Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones,” said FDA Center for Drug Evaluation and Research Director Dr. Patrizia Cavazzoni. “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.”
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The drug was approved using the FDA’s accelerated approval regulations, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatment.
“As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation,” said Cavazzoni