U.S. HIV specialist pharmaceutical company ViiV Healthcare on Wednesday said that the U.S. Food and Drug Administration (FDA) has approved Cabenuva cabotegravir and rilpivirine for every two month dosing for the treatment of HIV-1.
The treatment is for HIV in virologic ally suppressed adults on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
ViiV Healthcare is majority-owned by GlaxoSmithKline plc, with Pfizer and Shionogi Limited as shareholders.
Cabenuva is the first and only complete long-acting HIV treatment regimen and was first approved by the U.S. FDA in January 2021 as a once-monthly treatment for HIV-1 in virologic ally suppressed adults.
The U.S. 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.
dpa
