The FDA has approved ViiV Healthcare’s Rukobia (fostemsavir), 600mg extended-release tablets for adults who cannot be treated with other therapies due to resistance, intolerance or safety considerations.
Rukobia is a novel attachment inhibitor for the treatment of HIV-1 infection indicated for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection.
Significant advances over the past few decades have dramatically improved HIV treatment and for many, HIV is considered a manageable life-long condition. However, HTE adults – which account for approximately 6% of adults living with HIV who are on treatment – have little to no options left due to resistance, tolerability or safety considerations. 1 HTE adults are at risk of progressing to AIDS and death and in great need of additional therapies.
Deborah Waterhouse, CEO of ViiV Healthcare, 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.”
Rukobia was reviewed and approved under the FDA’s Fast Track and Breakthrough Therapy Designations which are intended to fast track the development of new drugs to address unmet medical need.
Fostemsavir is currently under review by the European Medicines Agency and additional submissions to regulatory authorities around the world are planned throughout 2020 and 2021.