FDA approves ViiV's novel HIV treatment Rukobia

The US Food and Drug Administration (FDA) has approved ViiV Healthcare's novel attachment inhibitor Rukobia (fostemsavir) expanding treatment options for HIV.

The decision allows physicians to prescribe the drug in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, who are failing their current ARV regimen due to resistance, intolerance or safety considerations.

Despite advances in treatment, HTE adults – which account for around 6% of adults living with HIV who are on treatment – have little to no options left due to resistance, tolerability or safety considerations, ViiV noted, highlighting the unmet need for the subset of people with the disease.

“There is a small group of heavily treatment-experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS. The approval of Rukobia is a culmination of incredibly complex research, development, and manufacturing efforts to ensure we leave no person living with HIV behind,” commented Deborah Waterhouse, ViiV's chief executive.

Approval was supported by data from the Phase III BRIGHTE study, which evaluated the safety and efficacy of Rukobia in combination with optimised background therapy (OBT) in HTE adults living with multidrug-resistant HIV, many of whom had advanced HIV disease at study entry.

In the randomised cohort, 60% of individuals who received Rukobia in addition to an investigator-selected OBT achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count through Week 96.

“As a novel HIV attachment inhibitor, fostemsavir targets the first step of the viral lifecycle offering a new mechanism of action to treat people living with HIV,” noted Jacob P. Lalezari, chief executive and director of Quest Clinical Research.

“In the BRIGHTE study, fostemsavir in combination with other ARVs effectively achieved and maintained long-term viral suppression and demonstrated clinically meaningful rise in CD4+ T-cell count even among heavily immunocompromised patients. These are exciting advances for the HTE population and an advancement the HIV community has long been waiting for.”