July 31 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.
(Reporting by Toni Clarke in Washington; Editing by Bill Trott)