EMEA positive opinion on using tipranavir and darunavir in younger patients
The EMEA press release on its April 2009 meeting included the following two positive opinions on using recently approved protease inhibitors in younger patients.
To extend the indication to the treatment of human immunodeficiency virus (HIV-1) infection in highly pre-treated adolescents with virus resistant to multiple protease inhibitors above the age of 12, and also to extend the indication in highly pre-treated children aged 2 to 12. The latter indication comes with a new oral solution formulation. Aptivus is currently indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.
To extend the indication to include the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced children and adolescents above the age of 6. This indication also comes with the new strengths 75mg and 150mg film-coated tablets. Prezista is currently indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in treatment-experienced adult patients.
EMEA press release Meeting highlights from the Committee for Medicinal Products for Human Use, 20-23 April 2009. (23April2009).