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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