J&J SUBMITS NDA FOR ITS FIRST HIV DRUG
Johnson & Johnson (J&J) has filed its first application to market an
HIV drug, one of three being developed by its European subsidiary, Tibotec Pharmaceuticals,
which J&J bought in 2002.
J&J recently filed the new drug application (NDA) for its experimental protease inhibitor, TMC114, designed to treat patients infected with HIV-1. Protease inhibitors typically are used in combination with other antiretroviral drugs to prevent the HIV virus from replicating. TMC114 works against HIV viruses that have developed resistance to other drugs and also works to reduce the rate of drug resistance development in the HIV virus, a J&J spokeswoman told FDAnews.
J&J based the NDA on the 24-week dose-finding phase of two Phase IIb randomized, controlled studies, POWER 1 and POWER 2. Results from the POWER 2 study showed TMC114 combined with another protease inhibitor, ritonavir, effectively treated patients with drug-resistant HIV. The results showed that 62 percent of patients in the patient group taking the highest dose of TMC114/ritonavir achieved the primary endpoint viral load reduction, compared to 14 percent in the control group. At 24 weeks, viral levels fell to undetectable levels in 39 percent of patients in the highest TMC114/ritonavir dose group compared with 7 percent in the control group.
A TMC114/ritonavir combination is currently in Phase III clinical trials with patients that have been treated for HIV as well as patients that have not yet been treated for HIV.
If TMC114 is approved, Tibotec Theraputics, a division of J&J's subsidiary Ortho Biotech, will commercialize the drug in the U.S.