(Alliance News) - Pharmaceutical giants GlaxoSmithKline PLC and Johnson & Johnson on Thursday noted the US Food & Drug Administration's approval of Cabenuva, the first long-acting regimen for the treatment of human immunodeficiency virus, created by ViiV Healthcare.
ViiV Healthcare is majority owned by London-based Glaxo, with New York-based Pfizer Inc and Osaka-based Shionogi Ltd as shareholders.
Cabenuva was co-developed by Janssen Pharmaceutical Co of New Jersey-based Johnson & Johnson and ViiV Healthcare, and consists of Janssen's rilpivirine and ViiV Healthcare's cabotegravir.
Cabenuva is the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1, or HIV-1, infection in adults.
ViiV Healthcare's Head of North America Lynn Baxter 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."
Adverse affects of the new drug include injection site reactions, fatigue, headaches, nausea and sleep disorders.
Glaxo noted however that Cabenuva was preferred by 9 out of 10 patients over the previous daily oral therapy.
Professor of medicine at the University of North Carolina Institute of Global Health & Infectious Diseases David Wohl 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. The FDA approval of Cabenuva underscores the value of community-centric research and I am pleased this new option will be available for those living with HIV."
By Greg Roxburgh; gregroxburgh@alliancenews.com
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