FDA Approves Truvada as HIV Preventative Drug

Back in May 2012, Pharmaceutical International reported on a US FDA expert panel's approval of the HIV prevention drug Truvada. Needed, to get the drug into the hands of US HIV patients, was approval from the US Food and Drug Administration itself.

Now, that approval's been given - a first-time event for this type of drug. It's a historic moment for the pharmaceutical industry at large - never before has an HIV preventative been given the green light.

The FDA's approval terms qualify Truvada for use by adults especially at risk of contracting HIV, including those potentially involved with people who already have the condition. The news has been widely-welcomed by many but not by everyone: some HIV campaign groups and health represent think, rather than make people safer, Truvada could actually encourage them to take risks they otherwise wouldn't.

FDA Truvada Approval

The FDA Truvada approval was announced in a statement, in which the regulator emphasised that the preventative should be one element of what it termed a ‘comprehensive HIV prevention plan', alongside regular tests for HIV and safe sexual practise. Truvada isn't a new drug in itself - in fact the FDA approved it eight years ago as an HIV treatment - but the FDA's 16 July ruling does represent a new approved used.

"In the 80s and early 90s, HIV was viewed as a life-threatening disease; in some parts of the world it still is", director at the FDA's Division of Antiviral Products, Debra Birnkrant, explained in a press release. "Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time. But it is still better to prevent HIV than to treat a life-long infection of HIV."

Truvada: HIV Preventative Drug

"Today's approval marks an important milestone in our fight against HIV", added FDA Commissioner Doctor Margaret Hamburg in further comments on the Truvada HIV preventative go-ahead announcement.

"Every year, about 50,000 US 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."

Image copyright Jeffrey Beall -courtesy Wikimedia Commons