European Commission Grants EMA Approval for Dolutegravir Dispersible Tablets For the Treatment of Children Living with HIV in Europe

[Full Letter to IMPAACT P1093 Sites]

To the IMPAACT P1093 Clinical Trial Sites - 

The IMPAACT P1093 Team is elated to inform you that on 14 January 2021 ViiV was notified that the European Commission has granted Marketing Authorisation (EMA) approval for the dolutegravir dispersible tablets (5mg) for paediatric populations living with HIV in Europe. This decision follows the US Food and Drug Administration approval for this pediatric formulation in June 2020. Dosing for dolutegravir dispersible tablets was approved by the EMA for treatment -naïve and -experienced children weighing ≥3kg  and age ≥4weeks, and aligns with that currently implemented in P1093.  The EMA authorization also included updated dosing recommendations of film coated tablets (10, 25 and 50mg) for children weighing ≥14kg and age ≥6years. Both the FDA and EMA approved dosing schedules utilize the weight-bands recommended by the World Health Organization for children weighing ≥3kg.

Dolutegravir pediatric regulatory submissions are now ongoing around the world to ensure that age and developmentally appropriate formulations can become a treatment option for the approximate 1.7 million infected children worldwide. The Clinton Health Access Initiative (CHAI) and ViiV Healthcare, with funding from Unitaid, are working together to accelerate the availability of dolutegravir dispersible formulations for use in low income and other countries where access to newer antiretroviral therapies have been limited. Through this partnership, FDA approval for the first generic formulation of dolutegravir dispersible tablets was granted to Viatris (formerly Mylan Pharmaceuticals) in late 2020. It is anticipated that these activities will continue to evolve and help lead to a future where no child with HIV will be left behind. The EMA Marketing Authorization is based on data from the ongoing P1093 and ODYSSEY (PENTA20) studies, which are being conducted in collaboration with the international pediatric research networks, IMPAACT and PENTA-ID.

The IMPAACT P1093 team would like to thank and commend the IMPAACT Network, ViiV Healthcare and many international clinical sites for their expertise, professionalism and hard work in conducting such a complicated clinical trial leading to regulatory approval for dolutegravir. We especially would like to thank the study participants and families for volunteering for this trial. 

With thanks on behalf of the IMPAACT P1093 Team.