FDA Approves Tibotec's Antiretroviral Etravirine
FDA on Friday approved Johnson & Johnson subsidiary Tibotec Pharmaceuticals' antiretroviral drug etravirine foruse by HIV-positive people with a history of drug resistance, the AP/Seattle Times reports. The drug is a non-nucleoside reversetranscriptase inhibitor that helps to block an enzyme that HIV needs tomultiply, according to the AP/Times.
The agency said it approved the drug, sold under the brand name Intelence, foruse in combination with other antiretrovirals (AP/Seattle Times,1/20). The approval was based on studies conducted among people who tookcombination therapies that included etravirine or a placebo for 24 weeks,Reuters reports. According to Tibotec, thestudies found that the viral loads of 60% of participants treated withetravirine were suppressed to undetectable levels, compared with 40% of peoplewho were given the placebo. The company added that etravirine is the first NNRTIfor HIV-positive people who have developed resistance to drugs in the sameclass of antiretrovirals.
According to FDA, the most common problems reported were skin rashes andnausea. The agency advised people who take the drug to contact a physician if arash develops. FDA also warned that people using etravirine might developinfections, adding that the long-term effects of the drug are unknown. PamelaVan Houten, spokesperson for Tibotec, said the drug's wholesale cost will be$5.45 per tablet. The approved dosing is four tablets daily, Reutersreports (Richwine, Reuters, 1/19). The drug is expected to beavailable wholesale within one week, the company said. Applications forapproval also have been submitted to the European Agency for the Evaluation ofMedicinal Products and with regulatory authorities in Australia, Canada,Russia and Switzerland (DowJones, 1/20).
Roger Pomerantz, president of Tibotec Research and Development, said that ithas been about 10 years since a new NNRTI came on the market. He added thatetravirine is more powerful than current NNRTIs and that it will take longerfor HIV-positive people to develop resistance (Corbett Dooren, Dow Jones/CNNMoney.com, 1/22). Tens of thousands of patients worldwide have developedresistance to NNRTIs and could be candidates for etravirine, Pomerantz said (Reuters,1/19).
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