EU approves Rukobia for HIV-1 infection – ViiV Healthcare
ViiV Healthcare, owned by GlaxoSmithKline, announced the European Marketing Authorisation of Rukobia (fostemsavir) 600mg extended-release tablets..
..for use in combination with other antiretroviral (ARV) therapies for the treatment of adults with multidrug-resistant HIV-1 infection, for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
The Marketing Authorisation Application (MAA) for fostemsavir is supported by data from the pivotal phase III BRIGHTE study, which evaluated the safety and efficacy of fostemsavir in combination with an optimised background therapy (OBT) in heavily treatment experienced (HTE) adults living with multidrug-resistant HIV, many of whom had advanced HIV disease at study entry. In the randomised cohort, 60% (n=163/272) of individuals who received fostemsavir in addition to an investigator-selected OBT achieved undetectable HIV viral load and clinically significant improvements to CD4+ T-cell count through Week 96.