Johnson & Johnson Seeks Full FDA Approval for HIV Treatment
February 13, 2009
Johnson & Johnson's Tibotec unit is requesting full Food and Drug Administration approval of its HIV drug Intelence, a non-nucleoside reverse transcriptase inhibitor designed for patients who have stopped responding to other treatments. FDA in January gave the drug preliminary approval under its accelerated approval program, allowing the company to market Intelence. In order to gain full approval, FDA required Tibotec to supply follow-up data on the drug's effectiveness. According to data submitted by Tibotec, 60 percent of patients taking Intelence for four months had undetectable HIV levels in their blood, compared with 39 percent of patients taking a placebo.
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.