FDA approval of Cabenuva for adolescents living with HIV
pharmafile | March 31, 2022 | News story | Business Services |
ViiV Healthcare, the global specialist HIV company, today announced the FDA approval of Cabenuva (cabotegravir, rilpivirine), for the treatment of HIV-1 in virologically suppressed adolescents who are 12 years or older, and weigh at least 35kg on a stable antiretrovial regiment. The approval marks the first time a long-acting HIV treatment is available for the adolescent population.
Patients must also have no history of treatment failure, and no known or suspected resistance to either cabotegravir or rilpivirine.
Lynn Baxter, Head of North America at ViiV Healthcare, said: “Adolescents living with HIV and their caregivers face notable treatment challenges with daily oral HIV therapy, including the stress and difficulties of taking medication every day.”
The regimen was co-developed as part of a collaboration with the Janssen Pharmaceutical companies of Johnson and Johnson.
Baxter added: “With today’s approval for Cabenuva, we are bringing this younger population a first-of-its-kind HIV treatment that is dosed as few as six times a year and removes the need for daily oral therapy altogether. At ViiV Healthcare, we are proud to deliver on our mission of leaving no person living with HIV behind and providing an innovative therapy to youth that addresses an unmet need is an important step forward.”
Cabenuva is the first and only complete long-acting HIV treatment regimen, and is approved a s once monthly or every-two-months treatment for HIV-1 in virologically suppressed adults and adolescents.
Cabenuva contains ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial.
The expanded indication for Cabenuva is supported by studies in adults and by data from the Week 16 interim analysis of the ongoing MOCHA (More Options for Children and Adolescents) study from ViiV Healthcare’s collaboration with the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT).
Ana Ovey
