STAT+: FDA agrees to review ALS treatment from Biogen, despite inconclusive clinical trial results

The Food and Drug Administration has agreed to review a treatment for a rare, genetically defined form of ALS developed by Biogen, even though results from a clinical trial failed to show a definitive benefit for patients.

Biogen said Tuesday that U.S. regulators accepted its application for the drug, called tofersen, and that it will undergo a priority review with an approval decision expected by Jan. 25.

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