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BRISTOL-MYERS DDI TREATMENT IND FILING EXPECTED BY MID-AUGUST, FDA

Executive Summary

BRISTOL-MYERS DDI TREATMENT IND FILING EXPECTED BY MID-AUGUST, FDA Commissioner Young told the House Government Operations/Human Resources Subcommittee Aug. 1. "We expect that the data will be submitted to the FDA somewhere in the middle of August," Young said in response to a question from subcommittee Chairman Weiss (D-N.Y.). Bristol-Myers has told the agency it is "analyzing the data now," Young testified. Once the application is submitted, he added, "we will act on it in the next thirty days." The hearing focused on AIDS patient care issues. FDA has expressed its willingness to make DDI available as a treatment for AIDS patients, especially those who are sensitive to AZT. Young recently voiced his support for reviewing DDI under a Treatment IND ("The Pink Sheet" July 24, p. 19). Phase II/III studies of DDI are scheduled to begin this fall. Bristol-Myers is currently developing protocols for three studies involving about 2,000 people. One study will evaluate two different doses of DDI in patients intolerant to AZT. Another study will include patients who have received long-term AZT treatment, and will evaluate whether they should continue with AZT or be switched to DDI. A third study will test DDI in AIDS patients who have never received AZT, or who have been on it for a short period of time.
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