• Dolutegravir is the first integrase inhibitor available as a dispersible tablet for children weighing at least 3kg and from four weeks of age
• The authorisation is an important step in fulfilling ViiV Healthcare’s commitment to bring optimised paediatric formulations of dolutegravir to children

ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Commission has granted Marketing Authorisation for Tivicay (dolutegravir) 5mg dispersible tablets, which are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in paediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least four weeks and weighing at least 3kg. This authorisation includes updated dosing recommendations, for Tivicay (dolutegravir) film-coated tablets (10mg, 25mg and 50mg) for children 6 years and older and weighing at least 14kg, bringing these in line with the World Health Organization weight bands.

Deborah Waterhouse, CEO of ViiV Healthcare, said: “Today’s authorisation is a really important milestone towards enabling children to have access to age-appropriate formulations of HIV medicine. Globally there are approximately 1.7 million children living with HIV and around 100,000 children dying each year from AIDS which is why we won’t stop doing all that we can to ensure that no child living with HIV is left behind.”

The EU Marketing Authorisation follows the US Food and Dru…