The FDA's approval requires Biogen to further study its ALS drug tofersen to further verify its clinical benefits.
in 2021, which indicated that tofersen failed to meet its main goal of slowing disease progression in patients with amyotrophic lateral sclerosis.
ALS, commonly known as Lou Gehrig's disease, is a progressive and fatal neuromuscular disease that causes nerve cells in the brain and spinal cord to break down over time. Those mutations can cause a protein called SOD1 to accumulate to toxic levels, which damages the nervous system and leads to the development of ALS.
Stephanie Fradette, Biogen's head of ALS development, said those SOD1 protein levels are "indirect evidence" that tofersen targets the rare form of ALS.Another protein called neurofilament light, or NfL, is more strongly associated with the disease's severity and progression in patients, she said.
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