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.

The company had not previously disclosed the FDA submission for tofersen, but waited for the agency to accept the filing before making a public announcement.

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