Prezista (darunavir) has been given the go-ahead by the EU for adults with no darunavir resistance-associated mutations (DRV RAMs) who meet other criteria.
Brian Woodfall, Vice President, Global Clinical Development, Tibotec, says the tablet will provide “another viable option” for patients.
In December 2010, the FDA approved this indication for use in the US.
The approval is based on 48-week data from the ODIN (Once-daily Darunavir In treatment-experieNced patients) trial which analysed the efficacy and safety of 800/100mg darunavir/ritonavir once-daily against 600/100mg darunavir/ritonavir twice-daily for adult patients with no DRV RAMs.
The study achieved its primary objective of demonstrating non-inferiority of darunavir/ritonavir once-daily compared with twice-daily.
Janssen is responsible for marketing darunavir in Europe.