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Glaxo Wellcome Ziagen

Executive Summary

Company begins enrollment of patients March 23 in an expanded access program for the anti-HIV therapy abacavir. Patients will receive Ziagen twice daily free of charge and will be encouraged to use other therapies to which they have not been exposed. Qualifying patients are those failing or intolerant to standard therapy, older than 13 and unable to construct a viable treatment regimen without Ziagen. An adult open label program in the U.S. has enrolled 1,900 patients and safety data have been collected on more than 3,000 patients. Approximately 3% of Ziagen patients have experienced a hypersensitivity reaction, and Glaxo warns that those patients should not take Ziagen again because it could be fatal. The company expects to file an NDA by mid-year...
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