PFE - ViiV Healthcare announces FDA approval of two-month dosing of Cabenuva for HIV

ViiV Healthcare, majority-owned by GlaxoSmithKline (NYSE:GSK), announced that the FDA approved an every-two-month dosing regimen of the company’s HIV therapy Cabenuva, a combination of cabotegravir and rilpivirine. Cabotegravir and rilpivirine were developed by ViiV and Janssen unit of Johnson & Johnson (NYSE:JNJ), respectively. They are offered as extended-release injectable suspensions in single-dose vials. Other shareholders of ViiV Healthcare include Pfizer (NYSE:PFE) and Shionogi Limited (OTCPK:SGIOF) (OTCPK:SGIOY). The regulatory decision, based on global ATLAS-2M phase IIIb trial results, allows the use of Cabenuva as few as six times a year in virologically suppressed adults with HIV-1 on a stable regimen, according to the company. The therapeutic combination is indicated for those with no prior treatment failure and resistance to either of the agents. In Jan. 2021, the FDA greenlighted Cabenuva as a once-month regimen for adults with HIV-1.

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ViiV Healthcare announces FDA approval of two-month dosing of Cabenuva for HIV