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FDA update: Cabenuva oral lead-in now optional
FDA update: Cabenuva oral lead-in now optional.
About this update from Gsk Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 9397F\n GlaxoSmithKline PLC\n 24 March 2022\n \n \n \n \n \n \n \n Issued: 24 March 2022, London UK\n \n \n \n \n \n \n ViiV Healthcare announces label update for its long-acting HIV treatment, Cabenuva (cabotegravir, rilpivirine), \n \n \n to be initiated with or without an oral lead-in period \n \n \n \n US FDA approval of updated label streamlines the initiation process for the first and only complete long-acting HIV treatment by allowing people to start directly with injections \n \n \n \n London, 24 March 2022 - ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (\"GSK\"), with Pfizer Inc. and Shionogi Limited as shareholders, today 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).1, 2\n \n \n 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.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.\n \n \n 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 ...