CHMP positive opinion for Tibotec's Prezista

The Committee for Human Medicinal Products (CHMP) has issued a positive opinion recommending approval for once-daily dosing of 800 mg Prezista (darunavir) with low-dose ritonavir as part of combination therapy in treatment-naive adults (those who have never taken HIV medication before). Darunavir, a protease inhibitor, was developed by Tibotec, a division of US healthcare major Johnson & Johnson's Janssen-Cilag, which is responsible for marketing the brand in Europe.

The opinion will be reviewed by the European Commission, which then has authority to approve medicines for use throughout the European Union.

The CHMP's decision is based on 48-week analyses of plasma HIV RNA levels and CD4+ cell counts from the ongoing, randomized, controlled, open-label Phase III trial titled ARTEMIS in antiretroviral treatment-naive HIV-1-infected adults. Patients received 800mg darunavir once daily with 100 mg ritonavir as part of combination therapy.