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22 Jan 2021 | 07:48

GlaxoSmithKline's ViiV gets FDA approval for 'Cabenuva'

(Sharecast News) - GlaxoSmithKline said on Friday that its HIV specialist company ViiV Healthcare has received approval from the US Food and Drug Administration (FDA) for 'Cabenuva', the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults. The FTSE 100 pharmaceuticals giant is majority owner of ViiV, with Pfizer and Shionogi holding minority stakes.

It said 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 regimen 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.

Before initiating treatment with Cabenuva, oral dosing of cabotegravir and rilpivirine is administered for about one month to assess the tolerability of each therapy.

The approval of Cabenuva was based on the pivotal phase 3 'ATLAS' and 'FLAIR' studies, which included more than 1,100 patients from 16 countries.

Before initiating treatment with Cabenuva, oral dosing of cabotegravir and rilpivirine was administered for around one month to assess the tolerability of each therapy.

In those studies, Cabenuva was as effective in maintaining viral suppression as continuing a daily oral three-drug regimen when injected intramuscularly in the buttocks once a month throughout the 48-week study period.

ViiV said that in both studies, the most common adverse reactions were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash.

Serious adverse events occurred in 4% of patients taking Cabenuva, with 3% of adverse events leading to withdrawal.

Cabenuva was preferred by nine out of 10 patients over their previous daily oral therapy in the studies.

"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," said ViiV's North America head Lynn Baxter.

"Cabenuva reduces the treatment dosing days from 365 days to 12 days per year. At ViiV Healthcare, we are dedicated to ensuring no one living with HIV is left behind, and adding this first-of-its-kind regimen to our industry-leading portfolio of innovative medicines reinforces our mission."

At 0947 GMT, shares in GlaxoSmithKline were up 0.44% at 1,370.8p.
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