WASHINGTON (AP) — A division of Johnson & Johnson has asked federal regulators to grant full approval to an HIV drug designed to treat patients who have stopped responding to other treatments.
The Food and Drug Administration gave Intelence preliminary approval in January under its accelerated approval program, which allowed J&J to market the drug. In order to gain full approval, FDA required the company to submit follow-up data on the drug’s effectiveness.
Data submitted by J&J’s Tibotec unit showed that 60 percent of patients taking the drug for four months had undetectable levels of HIV in their blood compared with 39 percent of patients taking a placebo.
Intelence is a non-nucleoside reverse transcriptase inhibitor, or NNRTI, that blocks the enzyme HIV needs to multiply.
Tibotec Therapeutics is a division of Ortho Biotech Products, L.P., a Johnson & Johnson company based in Bridgewater, N.J.
Shares of Johnson & Johnson rose 15 cents to $58.11.