Darunavir (TMC-114) approved in Europe
On 16 February, the European Commission granted a conditional Marketing Authorisation for the protease inhibitor darunavir (trade name Prezista, previously known as TMC114).
Approval is for use in highly pre treated adult patients who failed more than one regimen containing a protease inhibitor and was was based on safety and efficacy data from the POWER 1, 2 and 3 studies. A conditional marketing authorisation was granted to darunavir , taken in combination with ritonavir and other antiretrovirals, 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 European Agency for the Evaluation of Medicinal Products (EMEA) annually until full authorisation is granted.
For further information contact the Medical Affairs Team at Janssen-Cilag on 01494 567444 or by email at email@example.com
Source: Tibotec press release, Anti-HIV Medication Prezista Receives Conditional Marketing Authorization in the European Union. 16 February 2007.
Tibotec press release