FDA Approves Label Update for HIV Treatment Cabenuva, Making the Oral Lead-in Period Optional

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, has announced that the US Food and Drug Administration (FDA) approved a label update for Cabenuva (cabotegravir, rilpivirine) making the oral lead-in with cabotegravir and rilpivirine tablets optional.

Oral cabotegravir and rilpivirine can be taken for a month to assess tolerability to the medicines prior to initiating cabotegravir and rilpivirine injections, a regimen co-developed as part of a collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson, but this oral lead-in is now optional after clinical trial data demonstrated similar safety and efficacy profiles for both initiation methods (with or without the oral lead-in), ViiV said.

Cabenuva is the first and only 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, the company said.

Lynn Baxter, Head of North America at ViiV Healthcare, said: “Since launching Cabenuva, we have been keenly focused on optimising the user experience for both people living with HIV and healthcare providers. Today’s label update for the optional oral lead-in provides a streamlined initiation process for the regimen by allowing people to start directly on long-acting injections and underscores ViiV Healthcare’s ongoing commitment to providing innovative treatment options that address the evolving needs of the HIV community.”

This US FDA approval is 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, the company said.