ViiV Healthcare files with FDA and EMA for dispersible formulation of dolutegravir for children

Specialist HIV company ViiV Healthcare today announced it has made regulatory submissions to both the European Medicines Agency and the US Food and Drug Administration seeking approval of the first-ever 5mg dispersible-tablet (DT) formulation of dolutegravir (DTG; trade name Tivicay), as well as a simplified dosing regimen to optimize use of the existing DTG 50mg film-coated tablet (FCT) in pediatric HIV patients.

The availability of age-appropriate formulations is essential in ensuring children around the world have access to optimal life-saving treatments, says ViiV, which is majority owned by GlaxoSmithKline (LSE: GSK).

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 the availability of HIV testing, continued mother-to-child transmission, slow initiation of treatment and poor availability of optimized pediatric formulations of antiretrovirals.