GlaxoSmithKline Announces Plan to File ‘Concentrated’ Antiretroviral Drug For Marketing Approval By End of Year
GlaxoSmithKline announced yesterday that the company plans to file for marketing approval by the end of this year for a new "concentrated" antiretroviral drug that it is developing with Vertex Pharmaceuticals, Reuters reports. Thomas Stark, a member of the GSK development team, said that the company hopes to launch the second-generation protease inhibitor, known as 908, in the United States in the second half of 2003 and in Europe in the first half of 2004. The drug is administered with Abbott Laboratories' Norvir, another protease inhibitor, which is known generically as ritonavir. "[K]ey" Phase III clinical trial results, which GSK presented last week at the Sixth International Congress on Drug Therapy in HIV Infection in Glasgow, Scotland, showed that 68% of 660 previously untreated patients with advanced HIV infection had undetectable HIV levels after 48 weeks of treatment with the 908/ritonavir combination, compared with 65% of participants who were given Pfizer's protease inhibitor Viracept. "These results demonstrate the potency, durability and tolerability of 908/ritonavir once-daily in therapy-naïve subjects, with the added benefit of a low pill burden," study researcher Joseph Gathe said. The 908/ritonavir regimen consists of four pills a day, while most approved protease inhibitors require at least six pills a day, Gathe added (Reuters, 11/21).
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