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news.Tibotec has submitted a supplemental new drug application to the FDA for the Prezista tablets, for traditional approval and an expanded indication to include human immunodeficiency virus-1-infected, treatment-naive adults.
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The supplemental new drug application (sNDA) application includes 48-week data from two phase III studies, ARTEMIS (antiretroviral therapy with TMC114 examined in naive subjects) and TITAN (TMC114/ritonavir in treatment-experienced patients naive to lopinavir/ritonavir).
Prezista (darunavir), co-administered with 100mg ritonavir and with other antiretroviral agents, is currently indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor. This indication is based on Week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled trials of Prezista/ritonavir (Prezista/r) in combination with other antiretroviral drugs.