Up­dat­ed: Bio­gen throws it­self back in­to mud­dled da­ta ar­gu­ments with more de­tails on its an­ti­sense ALS drug

With a high­ly watched FDA de­ci­sion dead­line com­ing in late Jan­u­ary, Bio­gen and Io­n­is dropped the full da­ta on the Phase III study of their ALS drug tofersen in the New Eng­land Jour­nal of Med­i­cine on Wednes­day.

Bio­gen is look­ing for ap­proval for tofersen in a very small sub­set of ALS pa­tients — some 2%, ac­cord­ing to the pa­per — who have a SOD1 gene mu­ta­tion, which has pre­vi­ous­ly been linked to ALS. Tofersen is meant to re­duce lev­els of mu­tant SOD1 pro­teins.

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