ViiV Healthcare, the company, majorly owned by GSK, with Pfizer and Shionogi, has announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir) for HIV infected patients with limited treatment options.
Rukobia is indicated in combination with other antiretrovirals (ARV) therapies in heavily treatment-experience adults with multidrug-resistant HIV-1 infection. The drug is indicated in patients who have resistance, intolerance, or safety consideration with the current ARV regimen.
Rukobia is the first in class attachment inhibitor. The drug is the prodrug is temsavir, which gets attached to the glycoprotein 120 subunit on the surface of the virus, thereby preventing the attachment of the virus to the CD4+ T-cells.
The approval is based on the Phase 3 BRIGHTE trial; Rukobia was administered in combination with optimized background therapy (OBT) in heavily treatment-experienced patients. The study has enrolled 371 patients; all the participants with a viral load of ≥400 copies/mL and ≤2 classes of antiretroviral medications were left due to resistance, and safety concerns were enrolled. 60% of the heavily treatment-experienced patients received Rukobia had viral suppression and clinically meaningful outcomes through 96 weeks.
7% of patients discontinued the treatment because of adverse events.
The product has received breakthrough and fast track designation, which enables to expedite the development of new drugs which address the unmet clinical need.
Rukobia is under review by the European Medicines Agency.