EC broadens Prezista indication

The European Commission has decided to broaden the indication for Prezista (darunavir) in combination with ritonavir and other antiretroviral medicinal products to the treatment of HIV-1 infection in all treatment-experienced adult patients. Darunavir was developed by Tibotec Pharmaceuticals, based in Cork, Ireland, which is a unit of US health care major Johnson & Johnson. Last year, a conditional marketing authorization was granted to darunavir, taken in combination with ritonavir and other antiretroviral medicinal products. This earlier conditional approval limited the use of darunavir for the treatment of highly pre-treated adult patients who failed on more than one regimen containing a protease inhibitor. A full EC marketing authorization is expected by the end of this month.