WASHINGTON The Food and Drug Administration has approved etravirine tablets for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals.
Etravirine, sold under the name Intelence, helps block an enzyme that HIV needs to multiply. The drug was approved to be used in combination with other anti-HIV medications.
When used with other active anti-HIV medicines, etravirine reduces the amount of HIV in the blood and increases white blood cells that help fight off other infections. In addition, etravirine may reduce the risk of death or infections that can occur with a weakened immune system.
The FDA’s approval of etravirine is based on data from 599 adults who received etravirine in two trials. After 24 weeks of treatment, more of the patients who received etravirine along with background therapy experienced reductions in the level of HIV in their blood than did those who received a placebo and background therapy.
The drug, which is made by Tibotec Therapeutics, was given priority review by the FDA.