Specialist HIV company ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its Rukobia (fostemsavir) 600mg extended-release tablets to treat HIV in adult patients.
Rukobia is a novel attachment inhibitor, which is designed to treat HIV-1 infection, is specified for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection.
Rukobia’s active ingredient is fostemsavir, which is a first-in-class HIV-1 attachment inhibitor.
Fostemsavir is converted to temsavir after oral administration. Later, it is absorbed and exerts antiviral activity by attaching directly to the glycoprotein 120 (gp120) subunit on the surface of the virus, enabling to block HIV from attaching to host immune system CD4+ T-cells and prevent the virus from infecting those cells and multiplying.
The FDA approval was based on data from the phase III BRIGHTE study, which assessed 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.
ViiV’s BRIGHTE is an international, phase III, partially-randomised, double-blind and placebo-controlled study carried out in 371 HTE adults living with HIV-1 infection with multidrug resistance. The company has recruited the patients in either a randomised or nonrandomised cohort.
The FDA has evaluated and approved Rukobia as part of fast track and breakthrough therapy designations.
Fostemsavir is presently under assessment by the European Medicines Agency, while additional submissions to regulatory authorities across the world are planned throughout 2020 and 2021.
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.”
In January this year, ViiV Healthcare completed a regulatory filing in Europe seeking the approval for fostemsavir for the treatment of HIV-1 infection in adult patients having limited treatment options.