FDA approves, expands indication of HIV treatment Cabenuva

By The Science Advisory Board staff writers

March 30, 2022 -- Cabotegravir and rilpivirine (Cabenuva), an HIV treatment co-developed by ViiV Healthcare and Janssen, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV-1 in virologically suppressed adolescents who are 12 years of age or older.

The treatment 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.

Cabenuva is a once-monthly or every-two-months injectable treatment. The FDA approval is based on the First Long-Acting Injectable Regimen week 124 results, which indicated efficacy, tolerability, pharmacokinetics, and safety of Cabenuva, Janssen said in a release.

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