Unprecedented blood biomarker enables ALS drug approval
, all of which have modest effects on disease progression. The mechanisms underpinning these other drugs are not as precisely characterized at a molecular level as that of Qalsody: the drug reduces a mutated form of superoxide dismutase 1 , an enzyme that prevents oxidative damage. When mutated, the presence of toxic protein aggregates and the enzyme’s loss of function may both contribute to the disease pathology.
Any form of neuronal damage results in NfL release into the cerebrospinal fluid and the plasma, which can be readily measured by an immunoassay. NfL is not diagnostic of ALS — it is a non-specific marker of neuronal damage and is elevated in a range of other neurodegenerative diseases as well as ALS. In Biogen’s 28-week pivotal study, those on the drug had an average 55% reduction from baseline NfL concentrations, whereas those on placebo experienced an average 12% increase.
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