SACRAMENTO >> A federal judge ordered one of the world's largest pharmaceutical firms to keep open a drug study site that is helping an 11-year-old boy with a rare and potentially fatal disease. Hawaii boy gets
continuation of
drug therapyAssociated Press
The temporary restraining order issued by U.S. District Judge Lawrence Karlton bars the Baxter Healthcare Corp. from closing its study site in Hawaii and removing what's left of an experimental drug used to treat Kristian Davis of Honolulu.
Davis is one of the few people in the world who has hereditary angioedema, a genetic disorder characterized by severe and recurring soft-tissue swelling.
The experimental drug, C-1 esterase inhibitor, has been effective in treating the disease in other countries but has not been approved for general use in the United States.
The Food and Drug Administration designated it as an orphan drug in 1999. That designation allows clinical development but not general distribution.
Baxter contends there are other, more effective ways to treat Davis and that C-1 esterase inhibitor has not been shown to be effective enough to be licensed by the FDA.
But the physician treating Davis and the study site's clinical investigator, Dr. Robert Wilkinson, says in a court declaration that the drug has been effective in treating Davis and "restoring a semblance of normalcy in his life."
Baxter Healthcare Corp.
Food and Drug Administration