2 Jul 2020 - Today, the U.S. FDA approved Rukobia (fostemsavir), a new type of anti-retroviral medication for adults living with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations.
The safety and efficacy of Rukobia, taken twice daily by mouth, were evaluated in a clinical trial of 371 heavily treatment-experienced adult participants who continued to have high levels of virus in their blood despite being on antiretroviral drugs.
The FDA granted this application fast track, priority review and breakthrough therapy designations.