FDA skeptical of experimental ALS treatment pushed by patient advocates
By MATTHEW PERRONE
AP Health Writer
WASHINGTON (AP) — The Food and Drug Administration meets this week to consider a much-debated treatment for Lou Gehrig’s disease. The deadly neurological disease has few treatment options. NurOwn, a stem cell therapy, is at the center of a yearslong lobbying campaign by patients seeking access to experimental medicines. But the FDA has repeatedly rebuffed drugmaker Brainstorm. The agency says the company’s only study failed to show a benefit for patients. The review is the starkest test yet of FDA’s commitment to “regulatory flexibility” to help patients with rare, deadly conditions. Advocates see reasons for optimism. The FDA has approved two new treatments for ALS in the past year after intense lobbying by patients.
