The pharmaceutical industry may be on the verge of one of the greatest breakthrough’s that this generation has ever seen. What you may ask would be so big, and so newsworthy? How about the prevention of HIV?!
One of the latest statistics state that annually around 2.7 million people become infected with HIV, so there are now an estimated 34 million people around the world who are living with HIV, including millions who have developed AIDS. And, approximately 1.8 million people die from AIDS each year. And, although there are more than 20 antiretroviral drugs approved for the treatment of HIV infection in the US and Europe, as well as many new HIV drugs currently undergoing trials, access to antiretroviral treatment is limited.
Therefore, if it were possible to prevent HIV, and therefore ultimately prevent AIDS, this would be an amazing discovery. And, one company, Gilead Sciences, has presented material to the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA), in hopes of gaining approval for this revolutionary treatment.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
Gilead Sciences, Inc. has just recently announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada® (emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP. If the FDA decides to approve Truvada for PrEP, it would be the first agent indicated for uninfected individuals to reduce their risk of acquiring HIV.
In response to questions posed to the committee, members voted 19 to 3 in favor of approval for Truvada for PrEP in men who have sex with men; 19 to 2 (with 1 abstaining) in support of use in HIV-uninfected partners in serodiscordant couples; and 12 to 8 (with 2 abstaining) in other individuals at risk for acquiring HIV through sexual activity.
The recommendations of the Advisory Committee are not binding, but will be considered by the FDA as the agency completes its six-month priority review of Gilead’s supplemental New Drug Application (sNDA) of Truvada for PrEP. Gilead submitted the sNDA on December 15, 2011 and the FDA has established a target review date under the Prescription Drug User Fee Act (PDUFA) of June 15, 2012.
The committee’s positive recommendation followed presentations of efficacy and safety data from several clinical studies of Truvada for PrEP, including two large placebo-controlled Phase 3 trials sponsored by the U.S. National Institutes of Health and the University of Washington, respectively. Several other clinical studies support the use of Truvada for HIV risk reduction.
Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the United States. Truvada is currently not indicated for HIV prevention.