The Food and Drug Administration (FDA) has granted priority review status for etravirine (also known as TMC125), according to an announcement by Tibotec Pharmaceuticals Ltd. Etravirine is an experimental non-nucleoside reverse transcriptase inhibitor (NNRTI) that was designed to be effective in people who had developed drug resistance to other NNRTIs.
The priority review status was granted for etravirine based on two studies presented at the International AIDS Society’s conference in Sydney this past summer (see our report). In the studies, called Duet 1 and Duet 2, researchers compared etravirine (200 mg) to placebo, both combined with a background regimen in treatment-experienced patients with documented resistance to NNRTIs and protease inhibitors (PIs). Participants who took etravirine in both studies were far more likely to achieve a viral load of fewer than 50 copies than those who received a placebo.
Priority review at the FDA was designed to provide a quicker path to approval for drugs that meet an unmet medical need. According to Tibotec, the FDA must take action on the application for etravirine, accepting it for approval or not, on or before January 18, 2008. Currently etravirine is available for adults in the United States who have few other treatment options through an expanded access program.