Patients suffering from Lou Gehrig’s disease shouldn’t have to plead with bureaucrats to try potentially lifesaving drugs.
In the next few days, the U.S. Food and Drug Administration (FDA) is expected to decide whether to accelerate approval of a new drug that might save the lives of patients with amyotrophic lateral sclerosis (ALS), Lou Gehrig’s disease. The manufacturer, Genervon Biopharmaceuticals, requested the approval of GM6 in February after finding improvements in patients during preclinical, Phase 1 and Phase 2A trials — with no negative side effects. If the FDA grants the request, patients would gain immediate access to the drug.
Efforts to speed up approval were triggered, in part, by ALS patient Anthony Carbajal, who a little over a year ago launched a petition on Change.org urging the FDA to allow him, his mother, and others — approximately 30,000 Americans suffer from ALS — to use the new drug. To date, more than 500,000 people have signed the petition.