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news.Specialist HIV company ViiV Healthcare has secured the US Food and Drug Administration (FDA) approval for the expanded labelling of Cabenuva (cabotegravir, rilpivirine) to treat HIV-1 in adults.
FDA approves the use of Cabenuva to every two-month dosing. Credit: Darwin Laganzon from Pixabay.
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Cabenuva has now been cleared for every-two-month dosing for the treatment of HIV-1 in people who are virologically suppressed on a stable regimen, with no prior treatment failure, and resistance to either cabotegravir or rilpivirine.
In January last year, the regulator approved the drug as a once-monthly treatment for HIV-1 in virologically suppressed adults.
Cabenuva is claimed to be the first and only complete long-acting regimen to treat HIV-1 in virologically suppressed adults.
It is a combination of Janssen Sciences’ rilpivirine and ViiV Healthcare’s cabotegravir. They are offered as extended-release injectable suspensions in single-dose vials.ViiV Healthcare North America head Lynn Baxter said: “ViiV Healthcare is pleased to continue our leadership in researching and developing long-acting innovative HIV treatment options that address the evolving needs of the HIV community.
“Today’s approval is a remarkable achievement given where HIV treatment was just a decade ago. We know some people living with HIV struggle with taking daily oral pills, and Cabenuva may allow them to maintain viral suppression while significantly reducing dosing to as few as six times a year.”
The regulatory decision is based on the data obtained from the global ATLAS-2M Phase IIIb trial, which is being conducted in 1,045 participants.
The findings from the trial showed that the use of Cabenuva every-two-month was non-inferior to once-monthly dosing.
In this study, the virologic suppression rates were found to be similar for every-two-month dosing and once-monthly dosing of Cabenuva.
The trial is being carried out at research centres in Australia, Argentina, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden and the US.
