People living with amyotrophic lateral sclerosis, or ALS, in the U.S. will have to wait longer than their counterparts in Europe and Canada for access to a potentially beneficial treatment, even though the medicine is being developed here.
Patient advocates have responded by accusing the Food and Drug Administration of ignoring the desperate needs of people with ALS and reneging on commitments to speed the approval of new medicines to treat the fatal, neuro-degenerative disease.
On Wednesday, Amylyx Pharmaceuticals of Cambridge, Mass., said the FDA denied a request to consider approving its ALS drug, called AMX0035, based on the results of a single, positive clinical trial completed last September.
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This is beyond outrageous. Unjustifiable. The FDA has gradually been losing respect among researchers and doctors. This tops their other brainless, heartless decisions.
Is the FDA afraid of side effects? These patients only wish they could put their demise on hold for “2-3 years” while you diddle about with your data and statistics.