New Products: Etravirine (Intelence)

After a priority review, the FDA has approved etravirine tablets (Intelence) to treat HIV infection in adults who have failed therapy with other antivirals. A nonnucleoside reverse transcriptase inhibitor (NNRTI) that helps to block an enzyme HIV needs to multiply, the drug was approved to be used with other active anti-HIV drugs. When taken as prescribed, etravirine reduces the amount of HIV in the blood and increases white blood cells that help fight off other infections. It may also reduce the risk of death or some infections.

The approval was based chiefly on data from 599 adults who received etravirine in two randomized double-blind, placebo-controlled trials. For more information on the trials, adverse events, and use in pregnancy, visit http://www.fda.gov/bbs/topics/NEWS/2008/NEW01783.html.