ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (GSK, GSK.L), with Pfizer and Shionogi Limitedas shareholders, said that the US Food and Drug Administration approved Cabenuva (cabotegravir, rilpivirine) for every-two-month dosing for the treatment of HIV-1 in virologically suppressed adults on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
Cabenuva is the first and only complete long-acting HIV treatment regimen and was first approved by the US FDA in January 2021 as a once-monthly treatment for HIV-1 in virologically suppressed adults.
The US FDA approval allows Cabenuva to be dosed monthly or every two months.
Long-acting cabotegravir and rilpivirine are approved for use every two months in Canada under the name Cabenuva and in the EU as Vocabria and Rekambys.
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