ViiV Healthcare’s Pediatric HIV Drug Approved

The FDA has approved ViiV Healthcare’s the supplementary new drug application (sNDA) for its dispersible drug tablet formulation of Triumeq PD (abacavir, dolutegravir and lamivudine) for the treatment of pediatric patients with human immunodeficiency virus type 1 (HIV-1).

The NDA was for the treatment of pediatric patients weighing between 10 and 25 kilograms (22 to 55 pounds). The agency also approved a supplemental NDA allowing the treatment for pediatric patients who weigh between 25 and 40 kilograms (55 to 88 pounds).

The European Medicines Agency is currently reviewing Triumeq for pediatric use.

ViiV Healthcare said it intends to allow for generic versions of dolutegravir to be manufactured and sold in a variety of developing countries, including locations in subSaharan Africa.