FDA will consult outside advisors on whether Biogen’s ALS drug can be approved on a biomarker
The FDA will ask a panel of outside experts if Biogen’s ALS drug should be approved on the basis of a new neurodegeneration disease biomarker.
US regulators plan to hold an advisory committee hearing on March 22 discussing the merits of Biogen’s application for its experimental ALS drug tofersen, according to a notice posted Monday in the federal register. It’s the second time the company will try to win an approval using a fresh biomarker after the Alzheimer’s drug Aduhelm as the FDA’s neuro department continues its shift toward patient accessibility.
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