Cork, Ireland (ots/PRNewswire) – - For Medical Media Only
- PREZISTA now Indicated for the Broad Range of Treatment-Experienced Patients in the 27 EU Member States
Tibotec Pharmaceuticals announced today that the European Commission adopted the decision to broaden the indication for PREZISTA(R) (darunavir), a protease inhibitor, 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, Cork, Ireland. Tibotec, a division of Janssen-Cilag, is the organisation responsible for marketing the brand in Europe.
“The availability of darunavir for the full spectrum of treatment-experienced patients in the European Union (EU) provides caregivers and patients with important additional options to manage HIV,” said Roger Pomerantz, M.D., President of Tibotec Research and Development. “Our scientists and development teams are deservingly proud of the difference they make in helping to address the unmet needs of people living with HIV. We will continue our commitment to developing innovative treatment options to help fight HIV and other infectious diseases.”
This Commission decision signifies that the treatment is authorised for use in the European Union, valid in all 27 EU member states. In 2007, a conditional marketing authorisation was granted to darunavir, taken in combination with ritonavir and other antiretroviral medicinal products. This earlier conditional approval limited the use of darunavir to the treatment of highly pre-treated adult patients who failed on more than one regimen containing a protease inhibitor. The full marketing authorisation from the European Commission is expected by the end of December 2008.
Following today’s decision, darunavir, co-administered with 100 mg ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced adult patients, including those that have been highly pre-treated.
The extended indication was based on the 48-week analysis of the phase 3 TITAN trial in treatment-experienced lopinavir/r-naïve patients. Forty-eight week results from TITAN in lopinavir/r-naïve, treatment-experienced adults:
– Seventy-seven percent of patients in the darunavir/r arm (n=298) vs. 67
percent of patients in the lopinavir/r arm (n=297) reached less than
400 copies/mL, (study demonstrated non-inferiority, p
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