Biogen Wins FDA Accelerated Approval for Rare ALS Treatment

The US Food and Drug Administration (FDA) issued an accelerated approval for Biogen’s drug Qalsody, a treatment for a rare form of amyotrophic lateral sclerosis (ALS). The decision was based on data that showed that the drug reduced levels of a key neurodegeneration marker by 55% at the 28-week time point.

According to Emily Kimber, “Additionally, an analysis at 52 weeks of those enrolled in the open-label extension (OLE) study showed similar NfL reductions in those previously receiving placebo and who initiated Qalsody in the OLE.”

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(Source: PM Live, April 26^th, 2023)