ViiV Healthcare : FDA Approves Label Update For Long-acting HIV Treatment Cabenuva

The US Food and Drug Administration approved a label update for long-acting HIV treatment Cabenuva (cabotegravir, rilpivirine), allowing patients to start the injectable treatment without an oral lead-in phase. Clinical data demonstrated a similar safety and efficacy profile with and without the oral lead-in, ViiV Healthcare said in a statement.

ViiV Healthcar, the specialist HIV company majority owned by GlaxoSmithKline plc, with Pfizer Inc. and Shionogi Limited as shareholders, noted that the oral cabotegravir and rilpivirine can be taken for a month to assess tolerability to the medicines prior to initiating cabotegravir and rilpivirine injections.

The FDA approval was based on the FLAIR phase III trial Week-124 results, which showed there were similar outcomes regarding maintenance of virologic suppression, safety, tolerability and pharmacokinetics in people starting cabotegravir and rilpivirine injections with or without the oral lead-in.

Cabenuva is complete long-acting HIV treatment regimen and is approved in the US as a once-monthly or every-two-month treatment for HIV-1 in virologically suppressed adults. 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.

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