FDA grants full approval to HIV drug Intelence based on follow-up data from J&J

Wednesday, November 25, 2009

FDA grants full approval to J&J’s HIV drug

BRIDGEWATER, N.J. — A division of Johnson & Johnson said Wednesday that federal regulators granted 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 2008 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.

More recent data submitted by J&J’s Tibotec unit showed that 60 percent of patients taking the drug for 48 weeks had undetectable levels of HIV in their blood compared with 38 percent of patients taking a placebo.

Intelence is a non-nucleoside reverse transcriptase inhibitor, or NNRTI, that blocks the enzyme HIV needs to multiply. The twice-daily tablet is already approved for use in 50 countries around the world.

Tibotec Therapeutics is a division of Ortho Biotech Products LP, a Johnson & Johnson company based in Bridgewater, N.J.

Shares of Johnson & Johnson rose 15 cents to $63.34.

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