Data from the ongoing P1093 and ODYSSEY (PENTA20) studies have led to the successful approval of ViiV Healthcare’s submission to the U.S. Food and Drug Administration (FDA) of the adult formulation for children weighing ≥20kg and dolutegravir (DTG) dispersible tablets for children of 4 weeks of age and older.
The approval of adult 50mg DTG for use for children weighing ≥20kg allows for immediate access to adult DTG formulation procured and available in many countries for the majority of children living with HIV. Dispersible DTG formulations will provide an age-appropriate option for a younger population making it easy for children who are unable to swallow tablets to take this medication. This successful submission is a major step in closing the gap between the HIV treatment options available for adults and children.
DTG tablets can be used in combination with other antiretroviral agents for the treatment of HIV-1 in paediatric patients (treatment-naïve or -experienced who do not harbour INSTI-resistant virus) aged at least four weeks and weighing at least 3kg.
The DTG paediatric submissions are currently under review by the European Medicines Agency (EMA) and other regulatory approvals around the world.
This is a significant milestone and would not have been possible without the collaboration between key partners, including the ODYSSEY trial and invaluable contribution from the ODYSSEY African trial sites. A special thanks to the ODYSSEY trial team at the MRC Clinical Trials Unit at University College London, UK, the ODYSSEY team at Penta, Italy and the PK team at the Radboud Institute for Health Sciences, Nijmegen. Their commitment and hard work was crucial to enable this submission.
The FDA regulatory approval is a cornerstone on which further work can be built towards timely access to optimal antiretroviral therapies (ART) for children living with HIV around the world.
Read more about the approved FDA submission in the ViiV Healthcare press release.