EU approves dolutegravir 5 mg dispersible for children older than four weeks

Polly Clayden, HIV i-Base

On 12 November, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion recommending marketing authorisation for dolutegravir 5 mg dispersible tablets for young children with HIV.

This formulation can be used as part of an ART combination to treating children aged at least four weeks and weighing at least 3 kg.

CHMP’s opinion follows the US Food and Drug Administration (FDA) paediatric approval earlier this year.

The positive opinion also supports the updated dosing recommendations for dolutegravir film-coated tablets for children aged 6 years and above and weighing at least 14 kg, including the adult 50 mg tablet for children weighing at least 20 kg.

Full EMA approval is expected in January 2021.

Reference
European Medicines Agency (EMA). Summary of opinion: Tivicay (dolutegravir). 12 November 2020.
https://www.ema.europa.eu/en/medicines/human/summaries-opinion/tivicay