U.S. Food And Drug Administration Approves Gilead’s Truvada® For Reducing The Risk Of Acquiring HIV

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada ^® (emtricitabine and tenofovir disoproxil fumarate), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. Truvada is the first agent to be approved for HIV prevention in uninfected adults, a strategy called pre-exposure prophylaxis (PrEP). As part of the approval, Gilead worked with the FDA to develop a Risk Evaluation and Mitigation Strategy (REMS) to help ensure safe use of Truvada for PrEP as part of a comprehensive prevention strategy. Truvada was originally approved in 2004 in combination with other antiretroviral agents as a treatment of HIV-1 infection in adults and is currently the most-prescribed antiretroviral product in the United States.

“Today’s decision is the culmination of almost 20 years of research involving investigators, academic and medical institutions, funding agencies and nearly 20,000 trial participants around the world, and Gilead is proud to have been a partner in this effort,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “This advancement in the field of HIV prevention was made possible due to the leadership and commitment of the FDA and the Department of Health and Human Services to reduce the number of new HIV infections in the United States and worldwide.”

It is estimated that 1.2 million Americans are currently living with HIV, and, despite the availability of existing prevention tools such as condoms, the incidence rate has remained steady over the past two decades with approximately 50,000 new infections occurring each year. Nearly one-quarter (23 percent) of new HIV cases occur among women, and more than half (61 percent) occur among men who have sex with men (MSM). In particular, young African American MSM bear a heavy burden of the epidemic, with new HIV cases among this group increasing by nearly 50 percent between 2006 and 2009.

1 2 3 4 5 Next › Last »