EU grants Marketing Authorisation to first-ever dispersible-tablet dolutegravir

On 12 January 2021, the European Medicine Agency approved the use of dolutegravir 5mg dispersible tablets for treating HIV in young children living in Europe. This decision was based, in part, on data from our ODYSSEY trial, which we are conducting in close collaboration with the MRC CTU at the University College London.

 The EMA also authorised updating dosing recommendations for dolutegravir film-coated tablets (10mg, 25mg and 50mg) for children six years and older and weighing at least 14kg, bringing these in line with the World Health Organization weight bands.

 This decision enables European children to now have access to age-appropriate formulations of HIV medicine and reduces the gap between the treatment options available for adults and children.

 The Marketing Authorisation of dolutegravir dispersible tablets by the European Medicine Agency follows the US Food and Drug Administration (FDA) approval in June 2020.

 Requests of regulatory approval are ongoing in other countries globally, to ensure that these new HIV treatments become available to children wherever they are needed. 


Read the Press Release by ViiV Healthcare.