Home » FDA Approves HIV Injection Treatment Cabenuva for Adolescents
FDA Approves HIV Injection Treatment Cabenuva for Adolescents
March 31, 2022
The FDA has expanded its approval of ViiV Healthcare’s Cabenuva (cabotegravir and rilpirivine) to include adolescents who are 12 years and older infected with human immunodeficiency virus-1 (HIV-1).
The expanded indication for the oral lead-in treatment prior to an injection regimen is for adolescents weighing at least 77 pounds with no resistance to either cabotegravir or rilpirivine.
The expanded approval was based on interim data from a phase 1/2 clinical trial with 155 participants, which showed efficacy at week 16, the companies said.
The FDA previously approved Cabenuva as an optional oral lead-in treatment for adults.
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