FDA Approves ViiV sNDA for Dolutegravir

FDA has approved a ViiV Healthcare supplemental NDA for dolutegravir 10mg and 25mg oral tablets, reducing the weight limit from at least 40kg to at least 30kg, in ages six to less than 12 years old, for the treatment of HIV-1 in children and adolescents. Dolutegravir is indicated for treating pediatric patients weighing at least 30kg living with HIV-1 who are treatment naïve and who are treatment experienced, as long as they have not previously taken an integrase inhibitor.

Approval was based on 24-week data from a Phase 1-2 open-label study called P1093 that was conducted in collaboration with the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network. IMPAACT P1093 is an ongoing pharmacokinetic, safety and efficacy study of dolutegravir plus optimized background regimen in children and adolescents infected with HIV-1 in age-defined cohorts, according to the company.