ViiV Healthcare receives FDA OK for new indication of Cabenuva
ViiV Healthcare has received the Food and Drug Administration's permission for Cabenuva (cabotegravir, 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 and weigh at least 35 kg on a stable antiretroviral regimen, with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
The regimen was co-developed as part of a collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson. This approval marks the first time a long-acting HIV treatment is available for the adolescent population, underscoring ViiV Healthcare’s commitment to delivering options for young people living with HIV, the company said.
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Cabenuva is the first and only complete long-acting HIV treatment regimen approved as a 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, a product of Janssen Sciences Ireland, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
"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," Lynn Baxter, head of North America at ViiV Healthcare, said.
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"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," Baxter said. "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.”