TIBOTEC'S PREZISTA RECEIVES CONDITIONAL APPROVAL IN EUROPE

Tibotec Pharmaceuticals announced that the European Commission (EC) has granted a conditional marketing authorization for Prezista (darunavir), a protease inhibitor for the treatment of HIV-1.

This decision by the EC signifies that the treatment is authorized for use in the European Union, valid in all 27 member states. A conditional marketing authorization was granted to Prezista for use in combination with ritonavir and other antiretroviral drugs because of its benefits for HIV-1 infected patients. However, additional safety and efficacy data will need to be submitted to the European Medicines Agency annually until full authorization is granted.

The timing of the availability of the product will be decided in discussions with national authorities and will vary from country to country.

The approval was based on 24-week safety and efficacy data from POWER 1 and POWER 2, two ongoing, randomized, controlled trials involving 255 treatment-experienced adults. The results were supported by a 24-week analysis of the open-label trials (the POWER 3 analysis) of 327 patients who were initiated at the recommended dose of 600 mg of Prezista boosted with 100 mg of ritonavir twice daily.

Prezista was developed by Tibotec, a division of Janssen-Cilag. Tibotec will commercialize the product in the Europe Union, Russia, Switzerland and other countries. The drug is already approved in the U.S. and Canada.