FDA approves Biogen’s Alzheimer’s drug
The drug, Aduhelm, had received mixed reviews following earlier clinical trials
The Food and Drug Administration (FDA) on Monday approved Biogen’s Alzheimer’s drug, marking the first new authorized therapy to treat the disease in nearly two decades. The drug, Aduhelm (aducanumab), had received mixed reviews following earlier clinical trials.
In a statement following the approval, Dr. Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, said the agency used the Accelerated Approval pathway, which is when the FDA "approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit."
The drug, which is the first approved for Alzheimer’s since 2003, works to remove sticky deposits of a protein called amyloid beta from the brain. Cavazzoni said in her statement that the clinical trials for Aduhelm were the first to show that a reduction in these plaques is expected to lead to a reduction in the clinical decline of patients.
The Alzheimer's Association called the approval "the beginning of a completely new future for Alzheimer's treatments."
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The uncertainty surrounding whether it would receive regulatory approval surrounds two phase 3 clinical trials. One study met the primary endpoint and showed a reduction in clinical decline, while the other did not. In November 2020, the Peripheral and Central Nervous System Drugs Advisory Committee had said it was not reasonable to consider the clinical benefit of the drug based on one successful study.
However, Cavazzoni said that despite not meeting the endpoint, there was still evidence of consistent and convincing reduction of amyloid plaque levels, and that the advisory committee did not discuss the Accelerated Approval option for the drug.
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"With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review," Cavazzoni said. "Further, the data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit. There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives."
Cavazzoni said the FDA "followed our usual course of action" during the review process, and reviewed all relevant data as well as perspectives from the patient community.
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"In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy."