US FDA approves first-ever dispersible tablet form of Tivicay PD for HIV in children

The US Food and Drug Administration as approved ViiV Healthcare’s Tivicay PD (dolutegravir) tablets for oral suspension for the treatment of HIV-1 infection in children as young as four weeks old and weighing at least 3kg, in combination with other antiretroviral treatments, as well as an extended indication to expand the use of the already approved Tivicay (dolutegravir) 50mg film-coated tablet in pediatric HIV patients weighing 20kg and above.

Pediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic. Latest statistics show there are 1.7 million children living with HIV, 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 optimized pediatric formulations of antiretrovirals, says ViiV Healthcare. Tivicay generated first-quarter sales of £412 million (~$525 million).

ViiV Healthcare, which is majority-owned by UK pharma major GlaxoSmithKline (LSE: GSK), submitted the application for this indication to the FDA in December 2019, and at the same time to the European Medicines Agency, where it is still under review. Additional regulatory approvals around the world are ongoing, according to the company. This FDA decision marks the first ever dispersible tablet formulation of dolutegravir to be approved.