ViiV Healthcare secures FDA approval for Rukobia combo in multidrug-resistant HIV-1
pharmafile | July 6, 2020 | News story | Sales and Marketing | FDA, HIV, ViiV Healthcare
ViiV Healthcare, the HIV specialist majority owned by GSK which also counts Shionogi and Pfizer among its shareholders, has secured FDA approval for a 600mg extended-release tablet formulation of Rukobia (fostemsavir) in the treatment of HIV-1, it has emerged.
The indication relates specifically to the treatment of heavily treatment-experienced (HTE) patients with multidrug-resistant disease –approximately 6% of adult HIV patients receiving treatment – for whom their current antiretroviral (ARV) regimen is not proving effective.
“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,” explained ViiV CEO Deborah Waterhouse. “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.”
Phase 3 data submitted in support of the US regulator’s decision showed that, when combined with optimised background therapy, 60% of 272 trial participants receiving Rukobia reached an undetectable HIV viral load alongside “clinically meaningful” improvements in CD4+ T-cell count after 96 weeks of treatment.
The FDA’s decision was made under the Fast Track and Breakthrough Therapy pathways. A decision on the drug from the European Medicines Agency as well as from other regulators worldwide is expected in the near future and coming year.
Matt Fellows
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