The Food and Drug Administration (FDA) on Monday granted approval for the first new Alzheimer’s treatment since 2003.
The decision comes as the debate over whether to approve Biogen’s drug aducanumab has stirred controversy, with some Alzheimer’s experts and an independent advisory committee opposing approval saying there’s not enough evidence that the drug is effective.
In a statement, a top FDA official on Monday said it decided to use an “accelerated approval” process to make drugs and therapies available to patients enduring “serious diseases where there is an unmet need” and “an expectation of clinical benefit.”
“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,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in the statement.
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