ViiV Submits Application for Expanded Use of Cabenuva as HIV Treatment for Use Every 2 Months

 ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, announced today the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the expanded use of Cabenuva (cabotegravir, rilpivirine). The sNDA seeks to expand Cabenuva’s label to include every 2-months dosing for the treatment of HIV-1 infection in virologically suppressed adults (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Cabenuva is a complete long-acting regimen with two separate injectable medicines, ViiV Healthcare’s cabotegravir and rilpivirine, a product of Janssen Sciences Ireland UC. The medication was approved by the FDA in January 2021 as a once monthly treatment for HIV-1 infection in virologically suppressed adults. Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.¹

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