Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
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Wall Street Journal - October 26, 2001
The approval comes six months after Gilead submitted the Viread New Drug Application to the FDA. An FDA panel threw its support behind Viread on Oct. 3
Viread is dosed as one 300 mg tablet once daily with a meal and will be available in pharmacies within days, Gilead said in a press release Friday evening.
Viread is the first nucleotide analogue reverse transcriptase inhibitor approved for the treatment of HIV, the company said.
The drug works by blocking reverse transcriptase, an enzyme involved in the replication of HIV. As a nucleotide, Viread remains in cells for longer periods of time than many other antiretroviral drugs, allowing for once-daily dosing, Gilead said.
FDA Panel Supports Approval of Gilead's New Drug for HIV (Oct. 4)
In controlled clinical studies, Viread has been shown to reduce the level of HIV in the blood for up to 48 weeks when added to patients' existing antiretroviral regimens, Gilead said.
Viread reduced viral load even in patients whose HIV has developed resistance to currently available antiretroviral drugs, as demonstrated in a multicenter, placebo-controlled Phase III study involving 552 treatment-experienced patients, the company said.
Gilead is conducting Study 903 to further evaluate Viread in treatment-naive patients with HIV infection. This 96-week trial is designed to compare a treatment regimen of Viread, lamivudine (3TC) and efavirenz with a treatment regimen of stavudine (d4T), lamivudine (3TC) and efavirenz in a blinded fashion in patients in the U.S., Europe and South America who haven't previously received antiretroviral treatment.
In May, Gilead submitted a Marketing Authorisation Application to the European Agency for the Evaluation of Medicinal Products. On Oct. 18, the European Union's Committee for Proprietary Medicinal Products recommended marketing approval of Viread in the 15 member states of the European Community.
In August, Gilead submitted an application seeking regulatory approval of Viread in Australia.
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