http://www.forbes.com/feeds/ap/2009/11/25/business-health-care-us-j-amp-j-hiv-drug_7159873.html
Associated Press, 11.25.09, 04:03 PM EST
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.
=> It is good if one can develop an HIV drug
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.
11.26.2009
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