U.S. health advisers have narrowly ruled against an experimental drug for the debilitating illness known as Lou Gehrig’s disease
FILE - A sign for the Food and Drug Administration is seen in Silver Spring, Md., on Thursday, Dec. 10, 2020. On Wednesday, March 30, 2022, federal health advisers narrowly ruled against an experimental drug for the debilitating illness known as Lou Gehrigs disease, a potential setback for patient groups who lobbied for the medications approval.
Fischbeck and other panelists said they hoped results of a larger study now underway would provide more evidence. Typically, FDA approval requires two large studies or one study with a “very persuasive” effect on survival. Dr. Teresa Buracchio, an FDA division director, said the agency had “benefitted enormously” from patients' input. But she added that the problems with Amylyx's data exist “even with the recognition that ALS is a rare disease, with a relentless course that has an enormous unmet medical need.”
Some ALS patients already take the two older drugs, purchasing the supplement online and getting a prescription for the liver medication.
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