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The FDA approved the first long-acting injectable therapy for people living with HIV, the agency said late Thursday.
Injectable cabotegravir-rilpivirine (Cabenuva) was approved for people with HIV who are virologically suppressed on a stable antiviral regimen with no history of treatment failure. It is administered once a month.
"Having this treatment available for some patients provides an alternative for managing this chronic condition," John Farley, MD, director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research, said in a statement.
In addition, the FDA approved a tablet formulation of cabotegravir (Vocabria), which the agency said should be taken with currently approved oral rilpivirine (Edurant) for a month prior to starting injectable cabotegravir-rilpivirine to ensure the medication is well tolerated.