Pharmaceutical company GlaxoSmithKline revealed on Thursday that ViiV Healthcare, its HIV venture with Pfizer and Shionogi, has received an approved label update from the Food and Drug Administration for its Cabenuva asset.
GSK stated the approval meant that an oral lead-in with cabotegravir and rilpivirine tablets to assess tolerability to the medicines prior to initiating injections, a regimen co-developed as part of a collaboration with Johnson & Johnson, was now optional after clinical trial data demonstrated similar safety and efficacy profiles for both initiation methods.
The FTSE 100-listed firm also highlighted that Cabenuva was “the first and only” complete long-acting HIV treatment regimen and that it has received approval in the US as a once-monthly or every-two-month treatment for HIV-1 in virologically suppressed adults.
ViiV Healthcare’s North American head, Lynn Baxter, 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.”
As of 1505 GMT, GSK shares were up 0.76% at 1,624.90p.
