ViiV Healthcare’s Rukobia has received a marketing authorisation in Europe for the treatment of adults with multidrug-resistant HIV-1 infection.
The EU has cleared Rukobia (fostemsavir) for use in patients who cannot otherwise receive a suppressive antiviral-regimen.
Rukobia – a first-in-class HIV attachment inhibitor – is designed to target the first step of the HIV lifecycle.
According to ViiV, the drug shows no cross-resistance to other currently approved antiretroviral classes, offering a new option for patients who are multidrug-resistant and at a higher risk of disease progression or death.
“The marketing authorisation for Rukobia marks a significant milestone, as it addresses a critical unmet need in HIV care for those with little or no treatment options left,” said Deborah Waterhouse, chief executive officer of ViiV Healthcare.
The marketing authorisation application for Rukobia is supported by data from the Phase III BRIGHTE study in heavily-pretreated, multidrug-resistant HIV patients.
In this study, 60% of individuals who received ViiV’s drug, plus an investigator-selected optimised background therapy (OBT) achieved undetectable HIV viral load and clinically significant improvements to CD4+ T-cell count through week 96.
Rukobia is also approved in the US, also for the treatment of adults with multidrug-resistant HIV.
