The Food and Drug Administration meets this week to consider approval of an experimental treatment for Lou Gehrig's disease, the culmination of a yearslong lobbying effort by patients with the fatal neurodegenerative disease. Those advocates still face one giant hurdle: FDA...
The Food and Drug Administration meets this week to consider approval of an experimental treatment for Lou Gehrig’s disease, the culmination of a yearslong lobbying effort by patients with the fatal neurodegenerative disease.
But with the backing of thousands of ALS patients, Brainstorm took the rare step of “filing over protest,” essentially forcing the agency to render a decision. ALS gradually destroys nerve connections needed for basic movements and functions, including breathing. Most people die within five years of diagnosis.
“We do not want the perfect to be the enemy of the good,” said Wallach, speaking through an interpreter. “The key is to have treatments that make it possible to turn ALS into more of a chronic disease and to allow all patients to live longer and hopefully see a cure.”The ALS Association, the largest organization in the field, has not endorsed Brainstorm’s bid for approval despite giving the company $400,000 in research funding.
NurOwn is made from stem cells collected from patients' bone marrow. The cells are processed in a lab with biological proteins designed to promote nerve growth, and then injected into the spinal column.
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FDA skeptical of experimental ALS treatment pushed by patient advocatesThe Food and Drug Administration meets this week to consider a much-debated treatment for Lou Gehrig’s disease.
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