For a more detailed rundown of Friday’s meeting, with slides from the presentations, click here.
A panel of outside experts resoundingly concluded Friday that clinical data did not support the approval of Biogen’s much-watched Alzheimer’s drug, aducanumab, while providing a rebuke to the Food and Drug Administration, whose reviewers had given the medicine a glowing appraisal.
Aducanumab has been a focal point for the pharmaceutical industry because the need for a medicine to treat Alzheimer’s is desperate, in both human and economic terms, and because of the huge financial windfall that would accrue to Biogen if the drug were approved. But the way the clinical studies were conducted generated controversy. They were initially stopped because they seemed unlikely to provide a benefit; a re-analysis of the data showed that one of two studies appeared to show a benefit while the other did not.
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