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FDA Approves Vertex Protease Inhibitor 908; Drug to Be Sold Under the Name Lexiva

October 21, 2003

The FDA on Monday approved GlaxoSmithKline and Vertex Pharmaceuticals' experimental protease inhibitor drug -- known as 908 -- for use in combination with other antiretroviral medications, Reuters reports (Richwine, Reuters, 10/20). In July, Vertex announced that the drug -- which is taken in pill form once or twice per day -- in the last of three late-stage clinical trials did not suppress the virus as strongly as the combination protease inhibitor lopinavir/ritonavir, which Abbott Laboratories sells under the brand name Kaletra. But Vertex found that 908 was as effective as Kaletra in suppressing the virus in patients who had already been treated with antiretroviral drugs (Kaiser Daily HIV/AIDS Report, 7/28). GSK -- the world's largest seller of HIV/AIDS medicines -- and Vertex plan to sell 908 under the name Lexiva, according to FDA spokesperson Jason Brodsky (Bloomberg/Boston Globe, 10/21). Dr. Debra Birnkrant, director of the FDA's division of antiviral drug products, said that Lexiva will offer HIV patients "a new option" to reduce the number of pills they take each day; other antiretrovirals require doses of up to eight pills twice a day. She added, "Pill burden-wise, Lexiva is somewhat of an improvement" (Reuters, 10/20). GSK will market Lexiva, and GSK and Vertex both will promote the drug in the United States and Europe (GSK release, 10/21).

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