Gilead Sciences, Inc. (GILD: Quote) said Monday that the U.S. Food and Drug Administration has approved Truvada as the first drug to reduce the risk of HIV infection in healthy people who are at high risk of contacting the virus that causes AIDS.
Truvada, a pill taken daily, is to be used in combination with safer sex practices, to lessen the risk of sexually acquired HIV infection in adults at high risk.
Truvada will carry a boxed warning to alert health care professionals and uninfected individuals that the drug should only be used by those confirmed HIV-negative prior to prescribing the drug and at least every three months during use.
To support the safe use of Truvada for HIV prevention, Gilead also will provide vouchers for free HIV testing and condoms, an opt-in service for regular reminders about HIV testing and subsidized HIV resistance testing for any individual who becomes HIV-positive while taking the drug.
Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling and regular HIV testing, the FDA said in a statement.
"Today's approval marks an important milestone in our fight against HIV," said FDA Commissioner Margaret A. Hamburg, M.D. "Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."
"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.
Truvada was originally approved by the FDA in 2004 for use in combination with other antiretroviral agents to treat HIV-infected adults and children 12 years or older.
Truvada sales for the first quarter of 2012 increased 13% to $758.3 million from $673.1 million in the same period last year, reflecting sales growth of 17% in the U.S. and 8% in Europe.
Gilead shares are currently trading at $51.85, up 68 cents or 1.33%. The shares trade in a 52-week range of $34.45 to $56.50.
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by RTT Staff Writer
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