Tenofovir DF Expanded Access.On February 1 Gilead Sciences announced a much-enlarged expanded access program for tenofovir DF (tenofovir diisoproxil fumarate fumarate /fu·ma·rate/ (fu´mah-rat) a salt of fumaric acid. fumarate a salt of fumaric acid. ), a potentially important new drug which is now in a phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the with over 500 treatment experienced patients (averaging more than five years of HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. treatment before beginning this trial). The new pre-approval program is limited to "patients who have failed commercially available antiretroviral treatment regimens, have limited treatment options and are at risk for disease progression." It is now open in the U.S. and France, and will soon begin in Germany, Italy, Spain, and the United Kingdom. Gilead hopes to apply for marketing approval for tenofovir DF in mid 2001 in both the U.S. and Europe, and the drug has been designated for fast-track evaluation by the U.S. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. . |
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