ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) Receives the US FDA’s Approval for Virologically Suppressed Adolescents with HIV
- The approval was based on the 16wk. interim analysis of P-I/II (MOCHA/ IMPAACT 2017) study to evaluate cabotegravir or rilpivirine in 155 patients aged 12 to ≤18yrs. with HIV-1
- The results showed that the efficacy of Cabenuva in adolescents was derived from adults with support from PK analyses showed similar drug exposure & the safety profile was consistent with the safety profile of cabotegravir + rilpivirine in adults, AEs (61%)
- The expanded indication for Cabenuva provides an option with 6 dosing days/yr. for HIV-1 in virologically suppressed patients on a stable antiretroviral regimen with no history of treatment failure & no known or suspected resistance to cabotegravir or rilpivirine
Ref: Businesswire | Image: ViiV
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