Pharmaceutical Business review

Prezista receives FDA approval for label update

Artemis (AntiRetroviral Therapy with TMC114 ExaMined In naive Subjects), an international, randomized, controlled, open-label, non-inferiority, Phase 3 trial compared the efficacy and safety of Prezista/r versus lopinavir/r in treatment-naive HIV-1-infected adult patients.

The 192 week trial demonstrated that 70% of patients in the Prezista/r arm reached an undetectable viral load as compared to 61% of patients in the lopinavir/r arm.

Virologic failure was 12% in the Prezista/r arm and 15% in the lopinavir/r arm.

Prezista was developed by Tibotec Pharmaceuticals and is marketed in the US by Janssen Therapeutics.