sexta-feira, fevereiro 16, 2007
Prezista (TMC114) recebe aprovação da EMEA
ANTI-HIV MEDICATION PREZISTA™ RECEIVES CONDITIONAL MARKETING AUTHORISATION IN THE EUROPEAN UNION
Centralised procedure authorises use in all 27 EU member states, plus others
Cork, Ireland, [16.02.07] – Tibotec Pharmaceuticals, Ltd. announced today that the European Commission has granted a conditional marketing authorisation for PREZISTA™ (darunavir, also known by the investigational compound number TMC114), a protease inhibitor for the treatment of HIV-1 infected patients.
This decision by the European Commission through a centralised procedure, signifies that the treatment is authorised for use in the European Union (EU), valid in all 27 EU member states.
A conditional marketing authorisation was granted to PREZISTA, taken in combination with ritonavir and other antiretroviral medicinal products, because of its benefits for HIV-1 infected patients, however, more evidence is yet to be provided. Additional safety and efficacy data will need to be submitted to the EMEA annually until full authorisation 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.
PREZISTA, 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 highly pre‑treated adult patients who failed more than one regimen containing a protease inhibitor (PI).[i]
The approval was based on 24-week safety and efficacy data from POWER 1 and POWER 2, two ongoing, randomised, controlled trials involving 255 treatment-experienced adults. The results were supported by a 24-week analysis of the open label trials (POWER 3 analysis) of 327 patients who were initiated at the recommended dose of 600 mg PREZISTA boosted with 100 mg ritonavir twice daily.[ii]