European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the marketing authorisation of ViiV Healthcare’s Tivicay (dolutegravir) in combination with other antiretroviral medicines to treat adults and adolescents over 12 years of age infected with HIV.
The drug 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.
The positive opinion is based on safety and efficacy data for the drug from four Phase III trials 1-4, which included people living with HIV who were new to treatment and also those with prior experience of treatment.
The trials also involved comparators representing antiretroviral treatments commonly used today in the battle against HIV.
In these trials, over 2,500 people were treated and the regulatory submission also included data in children aged 12 years and older.
ViiV Healthcare chief medical officer John Pottage said: "The CHMP’s positive opinion on dolutegravir puts us a step closer to offering this new treatment option to people across Europe who are living with HIV.
"We are committed to research that seeks to make advances in treatment options for people living with HIV.
"To make progress, thousands of patients have supported us through their participation in clinical development work and we recognise their commitment today with great gratitude."
The European Commission is expected to decide on the marketing authorisation of Tivicay early in 2014.
The drug has already been approved by the US Food and Drug Administration (FDA) and by Health Canada in August and October 2013, respectively.
Tivicay, a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, blocks HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells).
ViiV Healthcare is a joint venture company owned 76.5% by GlaxoSmithKline, 13.5% by Pfizer and 10% by Japan-based drug maker Shionogi.
Image: Tivicay tablets are available for oral administration. Photo: courtesy of ViiV Healthcare