FDA panel: Benefit of Baxter's immune therapy outweighs risk
(Reuters) - The benefits associated with Baxter International Inc's experimental treatment for certain diseases of the immune system outweigh the risks, an advisory committee to the U.S. Food and Drug Administration concluded on Thursday, paving the way for approval of the therapy.
The panel voted 15-1 that the available data show a favorable benefit to risk ratio for treatment, HyQvia, which is designed to treat primary immunodeficiency diseases.
These are genetic disorders in which certain cells of the immune system are missing, leading to a infections, recurrent pneumonia and abscesses of the organs.
The FDA is not obliged to follow the advice of its advisory panels but typically does so.
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