FDA Approves Rukobia for Some HIV Patients

FDA has approved ViiV Healthcare’s Rukobia (fostemsavir), described as a “new type of antiretroviral 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.” An agency statement says Rukobia’s safety and efficacy 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 most common adverse reaction to Rukobia was nausea, FDA says. Severe adverse reactions included elevations in liver enzymes among participants also infected with hepatitis B or C virus, and immune reconstitution syndrome.

FDA had granted the application fast track, priority review, and breakthrough therapy designations.