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GSK: ViiV Healthcare Gets FDA Approval For HIV Treatment Cabenuva - Quick Facts

GlaxoSmithKline plc (GSK,GSK.L) said Friday that its majority-owned specialist HIV company ViiV Healthcare has received approval from the US Food and Drug Administration for Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults.

Cabenuva is provided as a co-pack with two injectable medicines - ViiV Healthcare's cabotegravir and Janssen's rilpivirine - dosed once monthly, as an option to replace the current antiretroviral or ARV regimen.

The treatment is taken in those who are virologically suppressed on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.

Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.

Lynn Baxter, Head of North America, ViiV Healthcare, noted that Cabenuva reduces the treatment dosing days to 12 days per year from 365 days.

The approval of Cabenuva is based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies that included more than 1,100 patients from 16 countries.

ViiV Healthcare will begin shipping Cabenuva to wholesalers and specialty distributors in the US in February 2021.

The company noted that the New Drug Application for Vocabria (cabotegravir) 30 milligram oral tablets was also approved by the FDA. Vocabria is indicated, in combination with rilpivirine tablets, as a complete regimen for short-term treatment of HIV-1 infection in adults.

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