GlaxoSmithKline/Pfizer’s ViiV Healthcare receives EU approval for Tivicay

GlaxoSmithKline and Pfizer's joint venture ViiV Healthcare has announced that its new HIV drug Tivicay has been approved by the European Commission.

The integrase inhibitor has been endorsed for use in combination with other antiretroviral medicinal products for the treatment of HIV-infected adults and adolescents above 12 years of age.

Data from four pivotal phase III clinical trials involving 2,557 adults – as well as a fifth paediatric trial – has demonstrated the safety and efficacy of the drug among a broad population of patients.

The efficacy of Tivicay as a third agent was shown to be statistically superior to its comparator in two pivotal phase III studies and non-inferior in a third comparator study, while it was also associated with low rates of discontinuation due to adverse events.

Dr Dominique Limet, chief executive officer at ViiV Healthcare, said: "Today's approval of Tivicay is an important advance, opening the door to new treatment combinations for people living with HIV in Europe."

This comes after the drug was also approved in the US last year, where it received an accelerated regulatory review process.