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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending 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. The CHMP positive opinion 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: “Clinical studies in paediatric populations are challenging and it is only with the support of our dedicated research partners that we are able to reach milestones like these.  This CHMP positive opinion paves the way to expand the use of dolutegravir in a younger population because this tablet can be dispersed in water, making it much easier for a child to take their medication.”

The positive opinion follows the US Food and Drug Administration (FDA) paediatric indication approval earlier this year, expanding the use of dolutegravir by providing an age-appropriate formulation to a younger population to help to close the gap between HIV treatment options available for adults and children.

Amanda Ely, CEO of CHIVA (Children’s HIV Association) said: “The dramatic reduction in new HIV diagnoses in children we have seen in recent years is testament to the enormous actions and efforts of multiple stakeholders worldwide. Yet the development and availability of child-friendly formulations have lagged behind adult populations. Rapid diagnosis and access to medicines with support for adherence to effective treatment is essential to the survival of the 1.8 million children currently living with HIV globally.”

The CHMP’s positive opinion is based on data from the ongoing P1093 and ODYSSEY (PENTA20) studies, which are being conducted in collaboration with international paediatric research networks, IMPAACT and PENTA-ID. Earlier this year, the dispersible-tablet formulation of dolutegravir was approved for use in the US as Tivicay PD (dolutegravir) tablets for oral suspension, in combination with other antiretroviral agents for the treatment of HIV-1 in paediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least four weeks and weighing at least 3kg. In addition, the indication for Tivicay (dolutegravir) 50mg film-coated tablets was extended to paediatric HIV patients weighing 20kg and above.