EC approve new strength Prezista (J&J Janssen Cilag) for AIDS patients

The European Commission has approved a new Prezista (darunavir) 800mg tablet, from J&J Janssen Cilag, allowing people living with HIV to take one darunavir tablet once a day. Darunavir is indicated in combination with other antiretrovirals for the treatment of HIV-1 infection in treatment-experienced and treatment-naive patients with no darunavir resistance-associated mutations. This new tablet strength has been developed to allow patients taking darunavir once daily to reduce the number of darunavir tablets by half - a reduced pill burden which should make it easier for patients to manage their treatment.

The approval is based on study C176 which evaluated the 400 mg and 800 mg formulations. One hundred and twenty eight volunteers received treatment under fasting (n=83) or under fed conditions (n=45). The results of this study show that the rate and extent of absorption were similar between intake of a single 800 mg dose of darunavir formulated as one 800 mg tablet or two 400 mg tablets.