07:32 AM EST, 01/31/2025 (MT Newswires) -- GSK (GSK) said Friday that its majority owned ViiV Healthcare unit has received European Commission approval for Vocabria, in combination with Johnson & Johnson's ( JNJ ) Rekambys, for the treatment of HIV-1 infection in adolescents 12 years of age and older weighing at least 35 kilograms.
The marketing authorizations are backed by data from an ongoing phase 1/2 study of the combination therapy's safety, tolerability and pharmacokinetics, the company said, adding that 139 of the study's 144 adolescent participants remained virologically suppressed with the therapy.
The European Medicines Agency approved the combination of Vocabria and Rekambys in December 2020 for the treatment of HIV-1 in adults who are virologically suppressed, GSK said.
Pfizer ( PFE ) and Shionogi are also shareholders of ViiV Healthcare, according to the statement.