UK-based pharmaceutical company ViiV Healthcare has received US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for dolutegravir 10mg and 25mg oral tablets.
The approval for the drug will help patients to reduce their weight limit from at least 40kg to at least 30kg in children between six years and less than 12 years to treat HIV-I in children and adolescents.
Dolutegravir will be available for use in two paediatric populations that include paediatric patients who weigh at least 30kg and are living with HIV-I that has not been previously treated, and patients who have been previously treated but have not taken an integrase inhibitor.
ViiV Healthcare chief scientific and medical officer John C. Pottage said: "Through our research and development efforts, corporate social responsibility programmes, partnerships and access initiatives, we have made a difference for younger populations.
"This approval by the FDA provides more children and adolescents the option to be treated with dolutegravir in the US, and supports the global UNAIDS paediatric treatment target."
The approval is based on a 24-week data collected from the Phase I / II multi-centre open-label P1093 study conducted by ViiV Healthcare in partnership with the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network.
The study reveals that treatment with dolutegravir, as well as OBR, has generally been well tolerated and provided efficacy through to week 24 in HIV-I infected children and adolescents between six and 12 years of age and weighing at least 30kg.
In 2014, the pharmaceutical company granted a voluntary licence to the Medicines Patent Pool (MPP) and Aurobindo Pharma to allow the generic production of paediatric formulations of dolutegravir without paying a royalty in 121 countries where most children live with HIV.
Also, ViiV Healthcare is committed to further investigating the ability of dolutegravir to treat younger age-groups affected with HIV-I.