Rukobia FDA approval : ViiV Healthcare said that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets as a new treatment of HIV patients having limited treatment options.
According to the FDA, Rukobia is a new type of antiretroviral medication for adult HIV patients who tried various HIV medications and whose HIV infection cannot be treated successfully with other therapies due to resistance, intolerance, or safety considerations.
The attachment inhibitor has been indicated for use in combination with other antiretroviral (ARV) therapies.
Commenting on Rukobia FDA approval, Jeff Murray – deputy director of the Division of Antivirals in the FDA Center for Drug Evaluation and Research, said: “This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options.
“The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infection—helping people living with hard-to-treat HIV who are at greater risk for HIV-related complications, to potentially live longer, healthier lives.”
Rukobia FDA approval was granted based on the safety and efficacy data noted from a phase 3 clinical trial called the BRIGHTE study, which featured 371 heavily treatment-experienced adult patients who continued to have high levels of virus (HIV-RNA) in their blood in spite of taking antiretroviral drugs. The attachment inhibitor from ViiV Healthcare was given in combination with optimized background therapy (OBT) in heavily treatment-experienced (HTE) patients who are multidrug-resistant HIV, of which many of them had advanced HIV disease at study entry.
In the randomized cohort, 60%, that is 163 out of 272 patients subjected to Rukobia in addition to an investigator-selected OBT achieved undetectable viral load of HIV along with clinically meaningful improvements to CD4+ T-cell count through Week 96.
Deborah Waterhouse – CEO of ViiV Healthcare, commenting on Rukobia FDA approval, 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.”
Currently, Fostemsavir is being reviewed by the European Medicines Agency with additional submissions planned to be made to regulatory authorities across the world in 2020 and 2021.