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Executive Summary

SYNTEX' GANCICLOVIR: "NEW EVIDENCE" WILL BE REVIEWED BY FDA advisory committee at a May 2 meeting, FDA announced March 2. The new data, according to the agency, is from a variety of sources, including the National Institute of Allergy and Infectious Diseases (NIAID), which is sponsoring the Treatment IND for the drug and working with Syntex on ongoing clinical trials. Study data from outside the U.S. is also a possibility. "Several scientific sources have indicated that they have developed, or are soon likely to develop, new data on ganciclovir that might answer many of the questions about the drug's use for" cytomegalovirus (CMV) retinitis, FDA said. "To review these data in the most timely and effective manner, FDA has requested that this evidence be presented before its Anti-Infective Drugs Advisory Committee." The meeting provides the advisory committee with the chance for a second review of ganciclovir (Cytovene). In October 1987, the committee voted 11 to 2 against approval, citing the necessity for additional clinical data. The Cytovene NDA was submitted in December 1986. Cytovene has been available since February 1985 to AIDS patients and others with compromised immune systems that have CMV retinitis under a compassionate use protocol. In November 1988, FDA cleared use of the drug through its Treatment IND procedures ("The Pink Sheet" Dec. 5, 1988, T&G-6). Under the Treatment IND, AIDS patients with sight-threatening CMV retinitis can receive the drug. In January, Syntex and NIAID also began a clinical trial with ganciclovir in AIDS patients with peripheral CMV retinitis. That trial has one patient. AIDS patients with peripheral CMV retinitis who cannot enter the controlled trial may now receive the drug under an open use protocol. FDA announced the expanded open use protocol in a press release on the upcoming advisory committee meeting. The agency explained that while incoming data on ganciclovir is reviewed, FDA "is working with the company and NIAID to ensure that patients at any stage of CMV retinitis have access to the drug." For this reason, FDA continued, "AIDS patients with non-immediately sight-threatening CMV retinitis who cannot be enrolled in the controlled study will now have access to the drug through an open use protocol." According to the agency and Syntex, the AIDS patient population with peripheral CMV retinitis is very small -- roughly 20 patients per month.

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