The positive opinion from the Committee for Human Medicinal Products (CHMP), the committee responsible for the scientific assessment of new medicinal products, will be reviewed by the European Commission, which then has authority to approve medicines for use throughout the European Union.
The CHMP’s positive opinion 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 Artemis in antiretroviral treatment-naive HIV-1-infected adults. Patients received 800mg darunavir once daily with 100mg ritonavir as part of combination therapy.
Darunavir, a protease inhibitor, was developed by Tibotec Pharmaceuticals, and Tibotec, a division of Janssen-Cilag, is the organization responsible for marketing the brand in Europe.
The full marketing authorization from the European Commission for treatment-naive adult patients is expected in the coming months, the company said.