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In a controversial decision, FDA announced today that it had approved Biogen’s Alzheimer's drug, aducanumab.
“We ultimately decided to the use the Accelerated Approval pathway — a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit,” said the prepared statement from Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research.
An advisory committee of outside experts had voted against recommending approval. Clinical trial results for the drug have been mixed, and at one point the company shelved the drug before re-analyzing trial results and restarting the process for gaining FDA approval.