The Food and Drug Administration will convene a meeting of independent advisers to review a personalized cell therapy for ALS that the agency has previously refused to consider.
On Monday, BrainStorm Cell Therapeutics, maker of the experimental ALS treatment called NurOwn, said the FDA had agreed to hold an advisory committee meeting. A date has not been set. An FDA spokesperson declined to comment.
In recent months, FDA officials have promised to apply the “broadest regulatory flexibility” to reviews of ALS drugs, even for medicines for which patient benefit is uncertain. One such drug, called Relyvrio, was approved last September. Last week, the FDA received a vote of support from outside advisers that will likely lead to the approval of a treatment called tofersen made by Biogen.
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