Opinion: FDA should lead the way on new ALS treatments, not Canada and Europe
Following the Food and Drug Administration’s recent decision to give the green light to aducanumab, the first treatment approved for Alzheimer’s disease in nearly two decades, the agency has been loudly criticized by some for moving too quickly. In the case of another deadly neurological illness — amyotrophic lateral sclerosis, or ALS — it is moving too slowly.
Exactly one week after the aducanumab decision was made public, Amylyx, a pharmaceutical company based in Cambridge, Mass., filed a new drug submission to Health Canada for AMX0035, its promising treatment for ALS. Amylyx is also working on an expedited pathway with the European Medicines Agency. Although approval is not guaranteed by either of these agencies — the equivalents of the FDA — it would mean that Canadians and Europeans living with ALS could get this drug long before Americans.
