Johnson & Johnson’s HIV drug Prezista has received a recommendation for marketing approval in treatment-naïve patients in the European Union.

J&J’s Ireland-based unit, Tibotec Pharmaceuticals, says that the European medicines Agency’s Committee for Human Medicinal Products has issued a positive opinion recommending approval for once-daily dosing of 800mg Prezista (darunavir) with low-dose ritonavir as part of combination therapy in treatment-naive adults.

The CHMP's positive opinion is based on 48-week analyses of plasma HIV RNA levels and CD4+ cell counts from the Phase III trial called Artemis in antiretroviral treatment-naive HIV-1-infected adults. Patients received 800mg darunavir once-daily with 100mg ritonavir as part of combination therapy.

Prezista and ritonavir is currently indicated in combination with other antiretrovirals in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor. Darunavir was given conditional approval by the European Commission in February 2007 and full marketing authorisation for treatment-naive adult patients is expected in the coming months.