FDA ap­proves Bio­gen’s ALS drug tofersen, paving new road for ac­cel­er­at­ed path­way in neu­ro dis­eases

The FDA grant­ed ac­cel­er­at­ed ap­proval to Bio­gen’s treat­ment for a rare type of amy­otroph­ic lat­er­al scle­ro­sis, or ALS, giv­ing a small sub­set of pa­tients a new and much-need­ed treat­ment op­tion.

Bio­gen’s drug, tofersen, to be mar­ket­ed as Qal­sody, is meant for the 1% to 2% of ALS pa­tients who have a mu­ta­tion called SOD1. That equates to about 330 peo­ple in the US, with 120 pa­tients new­ly di­ag­nosed each year, ac­cord­ing to Bio­gen.

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