ViiV: FDA OKs Cabenuva for Use Every 2 Months, Expanding Label of First, Only Complete Long-Acting HIV Treatment

 ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Limited (Shionogi) as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva (cabotegravir, rilpivirine) for every-two-month dosing for the treatment of HIV-1 in virologically suppressed adults (HIV-1 RNA less than 50 copies per millilitre [c/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 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.1 It contains ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The US FDA approval allows Cabenuva to be dosed monthly or every two months.

https://www.businesswire.com/news/home/20220118006212/en/ViiV-Healthcare-Announces-US-FDA-Approval-of-Cabenuva-cabotegravir-rilpivirine-for-Use-Every-Two-Months-Expanding-the-Label-of-the-First-and-Only-Complete-Long-Acting-HIV-Treatment