Pharmaceutical International News - May 2012
HIV Prevention Drug Truvada Approved
Posted by Paul Fiddian - Pharmaceutical International's Lead Reporter on 11/05/2012 - 15:40:00
The US Food and Drug Administration's expert panel has given its approval to an HIV prevention drug -a first-time event.
The drug will now be assessed by the FDA itself and, if it agrees, it should then be brought to the market. While the FDA isn't bound to heed its panel's advice, there aren't that many previous episodes in which it's disagreed.
That's why, even at this stage, there's a strong future envisaged for Truvada - a once-daily drug intended to be distributed among communities where HIV infection's considered likely.
While the FDA panel Truvada approval's been criticised in some quarters, supporters stress how the global HIV and AIDS fight might now soon reach a new level. Opponents fear how, if the drug's commercialised, not only could society become more complacent but a new strain of HIV could emerge that no drugs can treat.
Truvada is currently FDA-approved as an HIV treatment but not as a preventative. However, two years ago, the drug - manufactured by Gilead Sciences of California - showed it could lower the risk of HIV developing in previously-uninfected gay men by up to 73 per cent.
HIV Prevention Drug Approved
Only three of the 21-strong Antiviral Drugs Advisory Committee declined to give Truvada their support and the HIV prevention drug approval encompassed several areas. First and foremost was the drug's use by uninfected gay men with more than one male partner but also covered were the partners themselves, plus other groups deemed high-risk.
"Today is an exciting day for HIV prevention", the Fenway Institute's Doctor Kenneth Mayer explained stated in comments made after the Antiviral Drugs Advisory Committee's vote. "Although [Truvada] is not a panacea, this approach can prevent many new infections and could dramatically impact HIV transmission worldwide."
The US FDA now has until mid-June to declare its verdict on Truvada as an HIV preventative.
HIV image copyright US National Institutes of Health
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