FDA Approves Tibotec's Antiretroviral Etravirine

FDA on Friday approved Johnson & Johnson subsidiary Tibotec Pharmaceuticals' antiretroviral drug etravirine for use by HIV-positive people with a history of drug resistance, the AP/Seattle Times reports. The drug is a non-nucleoside reverse transcriptase inhibitor that helps to block an enzyme that HIV needs to multiply, according to the AP/Times.

The agency said it approved the drug, sold under the brand name Intelence, for use in combination with other antiretrovirals (AP/Seattle Times, 1/20). The approval was based on studies conducted among people who took combination therapies that included etravirine or a placebo for 24 weeks, Reuters reports. According to Tibotec, the studies found that the viral loads of 60% of participants treated with etravirine were suppressed to undetectable levels, compared with 40% of people who were given the placebo. The company added that etravirine is the first NNRTI for HIV-positive people who have developed resistance to drugs in the same class of antiretrovirals.

According to FDA, the most common problems reported were skin rashes and nausea. The agency advised people who take the drug to contact a physician if a rash develops. FDA also warned that people using etravirine might develop infections, adding that the long-term effects of the drug are unknown. Pamela Van Houten, spokesperson for Tibotec, said the drug's wholesale cost will be $5.45 per tablet. The approved dosing is four tablets daily, Reuters reports (Richwine, Reuters, 1/19). The drug is expected to be available wholesale within one week, the company said. Applications for approval also have been submitted to the European Agency for the Evaluation of Medicinal Products and with regulatory authorities in Australia, Canada, Russia and Switzerland (Dow Jones, 1/20).

Roger Pomerantz, president of Tibotec Research and Development, said that it has been about 10 years since a new NNRTI came on the market. He added that etravirine is more powerful than current NNRTIs and that it will take longer for HIV-positive people to develop resistance (Corbett Dooren, Dow Jones/CNNMoney.com, 1/22). Tens of thousands of patients worldwide have developed resistance to NNRTIs and could be candidates for etravirine, Pomerantz said (Reuters, 1/19).