ViiV Healthcare wins FDA approval to lower weight limit for dolutegravir HIV drug in children and adolescents

It has approved the application for dolutegravier 10 milligram and 25 milligram oral tablets, reducing the weight limit to at least 30 kilograms from at least 40 kilograms, in ages 6 to less than 12 years old.

The approval was based on 24-week data from the Phase I/II multi-centre, open-label P1093 study, which demonstrated that treatment with dolutegravir plus optimised background regimen (OBR) was generally well tolerated.

It also provided efficacy through to week 24 in HIV-1 infected children and adolescents from 6 to 12 years of age weighing at least 30kg.

The study’s adverse event (AE) profile was similar to that for adults. The company said Grade 2 AEs reported by more than one patient were decreased neutrophil count (n=3) and diarrhoea (n=2).

There were no Grade 3 or 4 drug-related AEs reported, and no AEs resulted in discontinuation.

ViiV Healthcare chief scientific and medical officer John 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."

In 2014, the Medicines Patent Pool (MPP) and Aurobindo Pharma secured a voluntary license from ViiV Healthcare 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 the deals, Aurobindo and generics companies sub-licensed by the MPP are allowed to manufacture the new 10mg and 25mg formulations of dolutegravir, subject to local regulatory approvals.