Pharmaceutical giant GlaxoSmithKline (GSK) said ViiV Healthcare’s HIV treatment Cabenuva had been approved by the US Food and Drug Administration (FDA). The shares dipped 0.15% to £13.62.

ViiV Healthcare is a global specialist in HIV majority owned by Glaxo, Pfizer and Shionogi. Cabenuva is the first and only complete long acting regimen for the treatment of HIV-1 infection in adults.


Approval was based upon the pivotal phase three trial ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long Acting Injectable Regimen) studies across more than 1,100 patients in 16 countries.

Prior to initiating treatment an oral dosing of cabotegravir and rilpivrine is administered for around a month to assess the tolerability of each therapy.

Cabotegravir and rilpivrine are co-administered as two injections into the buttocks at the same appointment.

Lynn Baxter, head of North America at ViiV Healthcare commented, ‘Today's FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care.

‘Cabenuva reduces the treatment dosing days from 365 days to 12 days per year.’

ViiV Healthcare is a specialist in HIV treatment with a portfolio of 13 treatments that generates annual revenues of nearly £5 billion.


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Issue Date: 22 Jan 2021