Drug used to treat HIV gets approval from FDA

WASHINGTON — Tablets of the drug etravirine were approved Friday by the Food and Drug Administration for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals.

Sold under the trade name Intelence, etravirine is a non-nucleoside reverse transcriptase inhibitor, or NNRTI, that helps to block an enzyme that the human immunodeficiency virus needs to multiply, the FDA said. It was approved for use in combination with other anti-HIV medications.

Etravirine can reduce the amount of HIV in blood and increase white blood cells that help fight off other infections, the FDA said. It also may reduce the risk of death or infections that can occur with a weakened immune system.

The government gave etravirine a priority review, a status granted to medications aimed at treating serious or life-threatening conditions. Tibotec Pharmaceuticals, a unit of Johnson & Johnson, said last July that it had requested etravirine be placed on a fast track for review.

"This is another significant new product for many HIV-infected patients who are NNRTI-resistant and whose infections are not responding to currently available medications," said Dr. Debra B. Birnkrant, director of the FDA's Division of Antiviral Products.

About 10 percent of new HIV patients are infected with a virus that doesn't respond to therapy with at least one AIDS drug, according to the U.S. Centers for Disease Control.

The drug is distributed by Tibotec Therapeutics, a division of Ortho Biotech Products of Bridgewater, N.J.