ViiV Healthcare, majority owned by GSK, received FDA approval for Dovato (dolutegravir/lamivudine) to treat HIV-1 in adolescents aged 12 and older, weighing at least 25 kg. This marks the first oral, two-drug, single-tablet regimen for this age group. Approval is supported by the DANCE study and adult trials.
United Kingdom: ViiV Healthcare, a leading HIV specialist company primarily owned by GSK, with Pfizer and Shionogi as shareholders, has received approval from the U.S. Food and Drug Administration (FDA) for Dovato (dolutegravir/lamivudine). This approval is for the treatment of HIV-1 infection in adolescents aged 12 and older, weighing at least 25 kg, with no previous antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen, with no history of treatment failure and no known resistance to the individual components of Dovato.
This expanded indication marks the first availability of an oral, two-drug, single-tablet regimen for adolescents aged 12 to 18 living with HIV, highlighting ViiV Healthcare’s commitment to providing more therapeutic options for young people. The approval is based on data from the DANCE study, which evaluated Dovato in treatment-naïve adolescents, as well as evidence from well-controlled trials in adults living with HIV, including GEMINI-1 and GEMINI-2 (treatment-naïve adults) and TANGO (treatment-experienced adults). Results from the DANCE study, which included adolescents aged 12 to 18 weighing at least 25 kg with HIV-1 RNA levels between 1000 to ≤500,000 c/mL, showed that 26 out of 30 participants achieved and maintained viral suppression at Week 48. The safety and efficacy data from the DANCE study in adolescents were comparable to those observed in adults, with higher but clinically insignificant exposures for the components of Dovato.
Lynn Baxter, Head of North America at ViiV Healthcare, said, "This expanded indication for Dovato brings an oral, two-drug, single-tablet regimen to adolescents living with HIV, providing a complete HIV therapy with fewer ARV medicines – an important consideration for young people who will require lifelong treatment. As a leader in HIV, ViiV Healthcare is proud of our focused efforts to improve and expand care for children and adolescents and we remain committed to addressing the existing treatment gaps in these communities.”
According to TechSci Research, The FDA approval of ViiV Healthcare's Dovato for adolescents significantly impacts the healthcare market by expanding treatment options for younger HIV-1 patients. This approval enhances ViiV Healthcare's market presence and highlights the growing demand for specialized treatments. As a result, it is likely to drive increased investment and innovation in the HIV treatment sector, further stimulating market growth and offering new revenue opportunities for pharmaceutical companies.