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FDA approves J&J's new HIV drug

The FDA approves Tibotec Therapeutic's new HIV drug Intelence for use with other HIV drugs in adults who have not been helped by other antiretroviral drugs

The FDA has approved Johnson & Johnson Ortho Biotech Products' subsidiary Tibotec Therapeutic's new HIV drug Intelence (etravirine).for use with other HIV drugs in adults who have not been helped by other antiretroviral drugs.

Intelence belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs) that block an enzyme that HIV needs to multiply.

Intelence was developed based on its ability to counter HIV strains that resist NNRTI therapy in two studies.

Together, the studies included 599 adult HIV patients. Half of the patients got Intelence in addition to their other HIV drugs. The other half of the group got a placebo pill along with their other HIV drugs.

After six months of treatment, more patients in the Intelence group had a drop in their blood level of HIV than patients in the placebo group. The long-term effects of Intelence aren't known, and the drug's safety and effectiveness haven't been studied in children younger than 16 or in pregnant women.

In August 2007, the FDA approved Pfizer's Selzentry. The drug inhibits one of two pathways that HIV uses to infect cells rather than treating the virus itself as the other HIV drugs are designed to do.

Intelence was approved as part of the FDA's accelerated-approval mechanism, which is aimed at getting life-saving treatments to market faster by allowing companies to submit less clinical data than usually required. Companies obtaining accelerated approval must keep studying drugs after they are on the market to gain full approval.

27th January 2008

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