ViiV Healthcare has received the US Food and Drug Administration (FDA) approval for Rukobia (fostemsavir) to treat human immunodeficiency virus (HIV)-1 infection in adults with limited treatment options.
Rukobia is an attachment inhibitor meant for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (hte ) adults with multidrug-resistant infection.
The drug can be used in HTE patients not benefiting from their current ARV regimen because of resistance, intolerance or safety considerations.
ViiV Healthcare CEO Deborah Waterhouse said: “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.”
FDA approval comes after a review of results from the Phase III BRIGHTE clinical trial performed in 371 HTE adults with HIV-1 infection and multidrug resistance.
During the study, the safety and efficacy of Rukobia was assessed when given in combination with optimised background therapy (OBT ).
In the randomised cohort, 60% of participants on Rukobia plus OBT were observed to experience undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count through week 96.
At week 96, the proportion of subject who discontinued treatment with ViiV’s drug due to an adverse event was 7%. The most common adverse reactions were nausea, fatigue and diarrhoea.
Rukobia previously received the FDA fast track and breakthrough therapy designations. Currently, the drug is being reviewed by the European Medicines Agency, with additional regulatory filings planned for 2020 and 2021.
Last month, the FDA approved ViiV’s Tivicay PD (dolutegravir) tablets, in combination with other antiretroviral agents, to treat children with HIV-1 infection.