ViiV Healthcare receives EU Marketing Authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe
January 13, 2021: ViiV Healthcare 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 Drug Administration (FDA) approval of Tivicay PD in 2020, providing an age-appropriate formulation of dolutegravir for 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: “As an organisation, we continue our efforts to help support young people and families living with HIV manage the challenges of lifelong treatment and today’s authorisation helps to do this.
This news is a positive step forward in helping the many children and infants who may struggle to take their medicines in tablet form.”
The Marketing Authorisation 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.
Voluntary licensing of paediatric dolutegravir
Currently 15 generic manufacturers hold voluntary licences for paediatric formulations of DTG: one direct license and 14 through the Medicines Patent Pool (MPP).
Two generic manufacturers who hold paediatric dolutegravir sub-licences from the MPP— Mylan Laboratories Limited (Mylan) and Macleods Pharmaceuticals Limited (Macleods) — have been provided with the technical expertise of ViiV Healthcare and a financial incentive from Unitaid via CHAI, to accelerate the development, registration, manufacture and supply of generic dispersible formulations of dolutegravir for children in all low-income, all least developed, all lower-middle income, all Sub-Saharan African (SSA) and some upper middle-income countries as defined by World Bank Classifications at the date of signature of the licence agreement.
Mylan and Macleods have both submitted a new drug application for a scored dolutegravir 10mg dispersible tablet with Mylan receiving tentative approval under the FDA President’s Emergency Plan for AIDS Relief (PEPFAR) scheme at the end of 2020.”