FDA Approves New Gilead Antiretroviral Drug Emtriva for HIV Treatment in Adults

The FDA yesterday approved Foster City-based Gilead Sciences' experimental drug Emtriva for use in combination with other antiretroviral medications for the treatment of HIV in adults, the New York Times reports (Pollack, New York Times, 7/3). The drug, also known as emtricitabine, is the company's second once-daily antiretroviral to gain FDA approval (Jacobs, San Jose Mercury News, 7/3). The FDA in October 2001 approved Gilead's antiretroviral Viread, a nucleotide reverse transcriptase inhibitor, for the treatment of HIV-positive patients (American Health Line, 2/1/02). Emtriva, which Gilead obtained when it purchased Triangle Pharmaceuticals, is a once-daily nucleoside reverse transcriptase inhibitor, which blocks an enzyme HIV needs to replicate (Ranii, Raleigh News & Observer, 7/2). Gilead said that it hopes by 2005 to be able to compete with GlaxoSmithKline's Combivir, which combines Epivir and Retrovir, by launching a combination pill containing Emtriva and Viread, which would provide the convenience of once-daily dosing for two drugs, according to the Wall Street Journal (Hamilton, Wall Street Journal, 7/3). Gilead in April began to sell Viread at approximately one-tenth of its retail price to 68 developing countries (White, Los Angeles Times, 4/4). However, John Milligan, CFO of Gilead, said that because of the high cost of production, Emtriva would not be affordable to developing countries even if it were sold at cost. The company plans to offer the drug to developing countries after the completion of its efforts to streamline the manufacturing process and reduce production costs, Milligan said (Gellene, Los Angeles Times, 7/3). According to Gilead spokesperson James Loduca, Emtriva should be available in pharmacies next week. The wholesale price will be $252.83 for a one-month supply (Ranii, Raleigh News & Observer, 7/3).