FDA advisers vote against experimental ALS treatment pushed by patients

By MATTHEW PERRONE
AP Health Writer

WASHINGTON (AP) — Federal health advisers have voted overwhelmingly against recommending approval of an experimental treatment for Lou Gehrig’s disease, the fatal muscle-wasting disease. The panel of Food and Drug Administration experts met Wednesday to review a stem cell-based therapy that has been at the center of a yearslong lobbying campaign by patients. The FDA initially refused to review the therapy, but drugmaker Brainstorm filed its application against the agency’s recommendation earlier this year. FDA leaders will make a final decision on whether to approve the treatment later this year. In a review published ahead of Wednesday’s meeting FDA called the company’s application “incomplete” and “grossly deficient.”