U.S. FDA Approves CABENUVA (cabotegravir and rilpivirine) for Adolescents, Expanding the Indication of the First and Only Complete Long-Acting Injectable HIV Re
CABENUVA offers virologically suppressed adolescents 12 years of age or older living with HIV-1 an injectable treatment option with as few as six dosing days per year
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (cabotegravir and rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older, weigh at least 35 kg and are on a stable antiretroviral regimen, with no history of treatment failure, nor known or suspected resistance to either cabotegravir or rilpivirine.1,2 Co-developed as part of a collaboration with ViiV Healthcare, CABENUVA is the first and only complete long-acting HIV-1 treatment regimen, and the first to be made available for eligible adolescents, building on Janssen's ongoing commitment to fighting HIV and improving HIV treatment options for young people living with HIV.
CABENUVA is approved as a once-monthly or every-two-months treatment for HIV-1 in virologically suppressed adults and adolescents. It 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, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
"HIV remains one of the most significant challenges in global health, and as part of our decades-long commitment to fighting HIV, Janssen is working tirelessly to advance innovative new treatment options for young people living with HIV," said James Merson, Ph.D., Global Therapeutic Area Head, Infectious Diseases, Janssen Research & Development, LLC. "With this milestone, we're continuing to redefine how HIV can be managed so that even more people, including adolescents, can benefit from long-acting injectable therapies."
The expanded indication for CABENUVA is supported by studies in adults and by data from the Week 16 interim analysis of the ongoing (More Options for Children and Adolescents MOCHA) study from ViiV Healthcare's collaboration with the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT). The efficacy of CABENUVA in adolescents is extrapolated from adults with support from pharmacokinetic analyses showing similar drug exposure. The safety profile in adolescents with the addition of either oral cabotegravir followed by injectable cabotegravir (n=8) or oral rilpivirine (n=15) followed by injectable rilpivirine (n=13) was consistent with the safety profile established with cabotegravir plus rilpivirine in adults.
Based on data from the Week 16 analysis of the MOCHA study in 23 adolescents, adverse reactions were reported in 61% of patients receiving either cabotegravir or rilpivirine in addition to their current antiretroviral treatment. The majority of these individuals (86%) had a Grade 1 or Grade 2 adverse reaction. The adverse reactions reported by more than one patient (regardless of severity) were injection site pain (n=13) and insomnia (n=2). Two patients had Grade 3 adverse reactions of hypersensitivity (n=1) and insomnia (n=1). The Grade 3 adverse reaction of drug hypersensitivity led to discontinuation of rilpivirine during oral lead-in. Sixty-two percent of patients who received at least one injection of cabotegravir or rilpivirine reported at least one injection site reaction. All injection site reactions were Grade 1 or Grade 2.1
"We're proud of our longstanding efforts to address the needs of young people living with HIV," said Candice Long, President, Infectious Diseases & Vaccines, Janssen Therapeutics, a Division of Janssen Products, LP. "By advancing new treatment options to meet the unique needs of adolescents living with HIV, we can help build a future where young people are not defined or limited by their diagnosis."
The U.S. Centers for Disease Control and Prevention reported that people aged 13-24 accounted for 21% of all new HIV diagnoses in the U.S. and dependent areas in 2018.3 Adhering to treatment regimens can be difficult for children and adolescents, who may skip HIV medicine doses to hide their HIV-positive status from others.3 Having more treatment options available, including simplified and long-acting injectable regimens, may be important to ensuring that adolescents can receive treatment on their own terms.