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SYNTEX GANCICLOVIR NDA APPROVAL REQUIREMENTS ARE SUBJECT OF FDA-NIAID TALKS

Executive Summary

The clinical requirements for Syntex' Cytovene (ganciclovir) NDA for the treatment of AIDS-related CMV retinitis are the subject of discussions between FDA topside and National Institute of Allergy and Infectious Diseases Director Anthony Fauci. At a Feb. 7 hearing before the Senate Labor & Human Resources Committee, chaired by Sen. Kennedy (D-Mass.), FDA Commissioner Young said he contacted NIAID's Fauci "last week" about finding a way to substantiate the largely anecdotal safety and efficacy data available to support the ganciclovir NDA. The purpose of his communications with Fauci, Young said, is "to bring in some of these investigators who have this evidence . . . and have that evidence put in the file at FDA and see whether we've got enough information to make an evaluation." Young told the committee he would report on the outcome of his discussions with Fauci. Ganciclovir has been available on a compassionate use basis since February 1985 and under a Treatment IND since last December ("The Pink Sheet" Dec. 5, T&G-6). In December, FDA also announced that Syntex and NIAID would initiate a controlled clinical study involving approximately 20 new enrollees per month. To date, no patients have been enrolled in the study. Unless early interim analyses of the study show conclusive results, the trial may require up to 180 patients and last as long as two years, NIAID is estimating.

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