The U.S. Food and Drug Administration approved a new drug that combats drug resistance among "heavily treatment-experienced" HIV-positive people, drugmaker ViiV Healthcare announced Thursday.
The medication, called fostemsavir and marketed under the name Rukobia, is to be used in combination with other antiretroviral medications and will specifically address those whose regimens are not succeeding because of resistance, intolerance, or safety considerations.
“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," Deborah Waterhouse, CEO of ViiV, which is owned by GlaxoSmithKline and Pfizer, said in a statement. "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.”
The FDA approved Rukobia following a successful study where 60 percent of heavily treatment-experienced adults using the medication achieved viral suppression through 96 weeks. The new medication was approved under the FDA’s Fast Track and Breakthrough Therapy Designations, which expedites new drugs that treat serious or life-threatening conditions.
It's not clear when exactly Rukobia will be available to the public, but the approval was a huge step towards that goal.