The US Food and Drug Administration has approved the first-ever dispersible tablet formulation of ViiV Healthcare’s Tivicay (dolutegravir), used in combination with other antiretrovirals to treat HIV-1 infection in paediatric patients aged at least four weeks and weighing at least 3kg.
The regulator also approved an extended indication to expand the use of the already approved Tivicay 50mg film-coated tablet in paediatric HIV patients weighing 20kg and above.
Paediatric HIV remains a global issue, with the latest statistics showing that there are 1.7 million children living with the disease, and the majority of AIDS-related deaths among children still occur during the first five years of life.
‘Major obstacles persist for children, such as continued mother-to-child transmission, the availability of HIV testing, slow initiation of treatment and poor availability of optimised paediatric formulations of antiretrovirals,’ ViiV said in a press release.
According to Deborah Waterhouse, ViiV’s chief executive, availability of dispersible Tivicay will make it easier for young children to take the integrase inhibitor.
“The development and availability of age-appropriate formulations is essential in ensuring children have access to life-saving HIV treatments from an early age and as they grow.
“The support of our partners has been integral for this regulatory approval. We now need to continue our efforts to ensure this new dispersible formulation is available to children who need it around the world, in line with our mission to leave no person living with HIV behind,” she added.
Tivicay PD and the extended indication of the existing Tivicay 50mg film-coated tablet are both currently under review by the European Medicines Agency (EMA).
15th June 2020