New HIV medicine Tivicay® (dolutegravir) is approved in Europe
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21.01.2014
London, UK, 21 January 2014 | ViiV Healthcare’s new HIV medicine Tivicay® (dolutegravir) is approved in Europe |
ViiV Healthcare today announced that the European Commission has approved Tivicay® (dolutegravir), an integrase inhibitor, for use in combination with other anti-retroviral medicinal products for the treatment of HIV infected adults and adolescents above 12 years of age.
The Tivicay clinical development programme was comprehensive in its breadth, including people living with HIV who were new to treatment (naive), as well as those who had already been treated with other HIV medicines (experienced) and those who were infected with a virus that had developed resistance to previously available integrase inhibitors. The submission supporting today’s approval included data from four pivotal Phase III clinical trials in which 2,557 adults received treatment with Tivicay or a comparator1-4. The submission also included data from a fifth study in children aged 12 years and older5.
“Today’s approval of Tivicay is an important advance, opening the door to new treatment combinations for people living with HIV in Europe. Tivicay’s clinical development programme was only possible through partnerships with the people living with HIV and healthcare professionals who participated in it, and we aim to move forward together with them based on an absolute commitment to the HIV/AIDS global response,” said Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare.
Today’s approval of Tivicay is the European regulatory authorisation to market the medicine in each member state of the European Union. Tivicay will become available in each country as pricing and reimbursement processes are completed, with availability in some of the first countries anticipated in the immediate future.
“HIV treatment is not a question of ‘one-size fits all’ – especially now that treatment is something that patients will live with for many years,” said Dr John Pottage, Chief Medical Officer, ViiV Healthcare. “We continue to find measurable clinical differences among the treatments now available for use in combination therapy to combat HIV. Using the clinical data for Tivicay, doctors and people living with HIV can fully consider the effectiveness against the virus and the side effect profile that Tivicay may bring.”
Read more at http://www.gsk.com/media/press-releases/2014/viiv-healthcare_s-new-hiv-medicine-tivicaytm--dolutegravir--is-a.html
