Updated on 25 November 2013
Europe grants marketing nod to HIV drug Tivicay
Singapore: European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for UK-based ViiV Healthcare's Tivicay in combination with other antiretroviral medicines for the treatment of adults and adolescents over 12 years of age infected with human immunodeficiency virus (HIV).
Tivicay can be used in adult patients with and without resistance to the integrase class and in adolescents infected with HIV-1 without resistance to the integrase class.
There are approximately 35 million people living with HIV globally. Over the past few years, the authorization and subsequent use of new, potent antiretroviral agents has changed the landscape of HIV treatment. With these new medicines, most patients are now able to achieve sustained viral suppression.
However, new treatment options are still necessary to fulfil the needs of all patients. The agency is currently consulting on new draft guidance on the development of these medicines, taking into account changes in the therapeutic landscape.
Tivicay contains the new active substance dolutegravir, an integrase inhibitor. The medicine blocks an enzyme called integrase, which is involved in the reproduction of HIV, and therefore slows down the spread of infection.