10 June 2016 - - The US Food and Drug Administration has approved a supplemental New Drug Application for specialist HIV ViiV Healthcare's 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, the company said.

Dolutegravir, in line with the current label, will be available for use in two paediatric populations: paediatric patients weighing at least 30kg living with HIV-1 who are treatment naïve (not previously treated) and who are treatment experienced (previously treated), as long as they have not taken an integrase inhibitor.

This approval is based on 24-week data from the Phase I/II multi-centre, open-label P1093 study 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 optimised background regimen in children and adolescents infected with HIV-1 in age defined cohorts.

Results from the study show that treatment with dolutegravir plus OBR was generally well tolerated and provided efficacy through to week 24 in HIV-1 infected children and adolescents from 6 to 12 years of age weighing at least 30kg.

In 2014, ViiV Healthcare granted a voluntary licence to the Medicines Patent Pool and Aurobindo Pharma to allow the generic manufacture of paediatric formulations of dolutegravir without paying a royalty in 121 countries where most children with HIV live.

Under the terms of these agreements, Aurobindo Pharma and generics companies sub-licensed by the MPP are permitted to manufacture the new 10mg and 25mg formulations of dolutegravir, subject to local regulatory approvals.

This means that dolutegravir may be made available to children and adolescents weighing at least 30kg in low income, least developed, sub-Saharan African and middle income countries in the future, subject to local regulatory approvals.

The company said it is committed to further investigating the potential of dolutegravir in younger age-groups. The ongoing P1093 study is continuing the evaluation of dolutegravir in paediatric populations down to four weeks of age, weighing at least 3kg.

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi (TYO: 4507) joined in October 2012.

The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV.