In an­oth­er ac­cel­er­at­ed ap­proval quest, Bio­gen will send its ALS drug to the FDA de­spite in­con­clu­sive da­ta

The con­tro­ver­sial Aduhelm ap­proval con­tin­ues to re­ver­ber­ate in Bio­gen’s de­vel­op­ment strat­e­gy, as the FDA will re­view an­oth­er CNS drug from the biotech de­spite clin­i­cal tri­al da­ta like­ly to raise sig­nif­i­cant ques­tions over its ef­fect.

Reg­u­la­tors sig­naled they will take up Bio­gen’s pitch for tofersen to treat a ge­net­ic form of ALS, the com­pa­ny an­nounced Tues­day morn­ing, tab­bing it for pri­or­i­ty re­view and a de­ci­sion date of Jan. 25, 2023. The agency is plan­ning to con­vene its pan­el of ex­perts in an ad­vi­so­ry com­mit­tee hear­ing, Bio­gen added, sug­gest­ing the drug’s ap­proval is far from cer­tain.

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