ViiV Healthcare announces US FDA approval of the first-ever dispersible tablet formulation of dolutegravir, Tivicay PD, a once-daily treatment for children living with HIV

Dolutegravir is the first integrase inhibitor available as a dispersible tablet for oral suspension for children weighing at least 3kg and from four weeks of age. 

The FDA approval is testament to the commitments of global stakeholders spanning regulators, industry and non-profit organisations to develop new and innovative HIV medicines for children, most of whom live in resource-poor settings.[i]

London, 12 June 2020 – ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir) tablets for oral suspension, 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, as well as an extended indication to expand the use of the already approved Tivicay (dolutegravir) 50mg film-coated tablet in paediatric HIV patients weighing 20kg and above.[ii]  

Paediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic. Latest statistics show there are 1.7 million children living with HIV1, and the majority of AIDS-related deaths among children still occur during the first five years of life.[iii] Major obstacles persist for children, such as continued mother-to-child transmission, the availability of HIV testing, slow initiation of treatment and poor availability of optimised paediatric formulations of antiretrovirals.3,[iv]

Deborah Waterhouse, CEO of ViiV Healthcare, said: “I am delighted that our innovative approach to science has enabled us to achieve FDA approval of the first-ever dispersible tablet formulation of dolutegravir, now making it easier for young children to take this medication by dispersing the tablet in water. The development and availability of age-appropriate formulations is essential in ensuring children have access to life-saving HIV treatments from an early age and as they grow. The support of our partners has been integral for this regulatory approval. We now need to continue our efforts to ensure this new dispersible formulation is available to children who need it around the world, in line with our mission to leave no person living with HIV behind.”

Dolutegravir is the first integrase inhibitor available as a dispersible tablet for oral suspension for children as young as four weeks of age and weighing at least 3kg. Prior to this, dolutegravir was indicated in the US for children from six years of age and weighing more than 30kg.[v] This step will expand the use of dolutegravir by providing an age-appropriate formulation to a younger population and will help to close the gap between HIV treatment options available for adults and children.

Chip Lyons, President and CEO of the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), said: “Children are often forgotten in the global fight to end HIV/AIDS and face a unique set of challenges, particularly when HIV medication and treatments are often hard to swallow or tolerate.  Barriers like these have resulted in only half of the 1.7 million children living with HIV accessing the lifesaving treatment they need—and even fewer still reaching viral suppression. Families affected by HIV will benefit from ViiV Healthcare’s development of child-friendly formulations that aim to close the gap between treatment options available for adults and children. This tailored approach to paediatric treatment of HIV will help meet the urgent needs of this vulnerable population.”

The FDA approval is based on data from the ongoing P1093[vi] and ODYSSEY[vii] (PENTA20) studies, which has been generated from ViiV Healthcare’s collaborations with the Division of AIDS (DAIDS) at the US National Institutes of Health (NIH) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) for P1093, and the Paediatric European Network for Treatment of AIDS (Penta) and the Medical Research Council (MRC) Clinical Trials Unit at University College London for ODYSSEY. 

Through its voluntary licensing policy, ViiV Healthcare enables generic versions of dolutegravir to be manufactured and sold royalty-free in all least-developed, low-income, lower-middle-income and sub-Saharan Africa countries, as well as some upper-middle-income countries. In order to ensure licensees expedite the development and introduction of optimised paediatric formulations of dolutegravir to help the children most affected by HIV, the majority of whom reside in sub-Saharan Africa, ViiV Healthcare has worked with the Clinton Health Access Initiative (CHAI) and Unitaid since 2018 in a public-private partnership.[viii] Through this partnership, two generic manufacturers who hold paediatric dolutegravir sub-licences from the Medicines Patent Pool (MPP) — Mylan Laboratories Limited and Macleods Pharmaceuticals Limited — 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. A key milestone in this collaboration was recently achieved when Mylan submitted a new drug application for a scored dolutegravir 10mg dispersible tablet for tentative approval under the FDA President’s Emergency Plan for AIDS Relief (PEPFAR) scheme. The Macleods submission is imminent.

Today’s FDA approval is an important step in fulfilling ViiV Healthcare’s commitment to bring optimised paediatric formulations of dolutegravir to children. Additional regulatory approvals around the world are ongoing and required in order to ensure we and our partners can succeed in delivering these new HIV treatments at the speed and scale that patients need.

Tivicay PD and the extended indication of the existing Tivicay 50mg film-coated tablet are both currently under review by the European Medicines Agency (EMA).