Kimberly Smith, ViiV R&D chief (ViiV Healthcare)

Af­ter sting­ing FDA set­back, Glax­o­SmithK­line's Vi­iV fi­nal­ly notch­es US ap­proval for long-act­ing HIV in­jec­tion

Glax­o­SmithK­line’s HIV unit Vi­iV was dealt a sting­ing loss back in late 2019 when the FDA slammed the brakes on its ap­pli­ca­tion for a once-month­ly in­jec­tion based on man­u­fac­tur­ing is­sues. Now, with that road­block in the rearview, Vi­iV has fi­nal­ly made good on its promise to change the HIV game.

The FDA on Thurs­day ap­proved Vi­iV’s Cabe­nu­va (cabote­gravir and rilpivirine) as a long act­ing, once-month­ly ther­a­py for HIV-pos­i­tive adults who are vi­ro­log­i­cal­ly sup­pressed and on a sta­ble an­tivi­ral reg­i­men.

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