FDA Grants Full Approval to J&J's HIV Drug
December 8, 2009
Johnson & Johnson's Tibotec division has announced the Food and Drug Administration has granted full approval to its HIV drug Intelence. The twice-daily tablet, a non-nucleoside reverse transcriptase inhibitor that works by blocking an enzyme HIV needs to multiply, is already approved for use in 50 countries. Under its accelerated approval program, FDA in January 2008 gave its permission for the drug to be marketed in the United States. However, full approval was conditional upon follow-up data about the drug's effectiveness. These data showed that 60 percent of patients on Intelence for 48 weeks had attained undetectable HIV viral loads, compared to 38 percent of control patients. Intelence is intended for HIV patients who have stopped responding to other treatments.