Cabenuva FDA approval : ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its long-acting regimen Cabenuva for the treatment of HIV-1 infection in adult patients.
According to ViiV Healthcare, Cabenuva is being given as a co-pack with a couple of injectable medicines that include the company’s integrase strand transfer inhibitor (INSTI) – cabotegravir and Janssen’s non-nucleoside reverse transcriptase inhibitor (NNRTI) – rilpivirine.
Cabenuva is to be dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in people who are virologically suppressed on a stable regimen, who did not have any treatment failure, and with no known or suspected resistance to cabotegravir and rilpivirine.
Commenting on Cabenuva FDA approval, Lynn Baxter – ViiV Healthcare Head of North America said: “Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care. Cabenuva reduces the treatment dosing days from 365 days to 12 days per year.
“At ViiV Healthcare, we are dedicated to ensuring no one living with HIV is left behind, and adding this first-of-its-kind regimen to our industry-leading portfolio of innovative medicines reinforces our mission.”
ViiV Healthcare is a specialist HIV company that is majority-owned by GlaxoSmithKline (GSK) with Pfizer and Shionogi being the other shareholders.
Cabenuva FDA approval has been driven by the findings of the phase 3 ATLAS and FLAIR studies that featured over 1,100 patients from 16 countries.
Before beginning treatment with Cabenuva, oral dosing of cabotegravir and rilpivirine was given for nearly one month to understand the tolerability of each therapy. In both ATLAS and FLAIR studies, Cabenuva was as effective in sustaining viral suppression as continuing a daily oral three-drug regimen when injected intramuscularly in the buttocks monthly once throughout the 48-week study period.
Dr. David Wohl – professor of medicine at the University of North Carolina Institute of Global Health and Infectious Diseases in Chapel Hill, commenting on Cabenuva FDA approval, Lynn Baxter said: “Among the scientific community, we recognize the innovation behind Cabenuva is truly meaningful. Not only is it the first, complete long-acting regimen, which allows for a dramatic reduction in the frequency of dosing, but it also was preferred by most clinical trial participants when compared to their prior daily oral regimens.”