
Home » J&J SUBMITS NDA FOR ITS FIRST HIV DRUG
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.
KEYWORDS FDAnews Drug Daily Bulletin
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