Before Covid-19 came along, there was nothing that loomed larger in biotech than aducanumab, Biogen’s controversial treatment for Alzheimer’s disease.
On Nov. 6, the Food and Drug Administration is convening a meeting of outside experts to review the data from two Phase 3 clinical trials of aducanumab. At the end of the meeting, this panel of experts is expected to vote on whether the drug should be approved, or not. The FDA isn’t required to follow the panel’s recommendation, but it will surely factor heavily into whatever decision the agency ultimately makes.
Apart from the possible approval of Covid-19 vaccines later this fall, there won’t be a bigger binary event in biotech this year than the FDA’s aducanumab advisory panel. The outcome will trigger a huge move in Biogen’s stock price, one direction, or the other. If approved later by the agency, aducanumab would be the first new treatment for Alzheimer’s disease in two decades.
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