GSK's ViiV, post-FDA rejection, scores Canadian nod for once-monthly HIV regimen Cabenuva

GlaxoSmithKline HQ
Cabenuva's approval in Canada is its first. (GlaxoSmithKline)

Despite high hopes for its game-changing monthly HIV regimen Cabenuva, GlaxoSmithKline's ViiV Healthcare went back to the drawing board after the FDA slammed the drug's manufacturing late last year. But Canadian regulators had few concerns and now Cabenuva will be ready for launch in its first global market. 

ViiV Healthcare's long-acting Cabenuva (cabotegravir and rilpivirine) has been approved in Canada to replace daily antiretroviral regimens in patients who are virologically stable and suppressed, the drugmaker said Friday. 

Health Canada jointly approved orally administered Vocabria (cabotegravir) to be used as a short-term addition to Cabenuva.

Cabenuva, a kit with separate monthly injections of cabotegravir and Janssen's rilpivirine, was developed in collaboration with the Johnson & Johnson unit, ViiV said. J&J markets rilpirivine under the brand name Edurant in its oral dose form. 

RELATED: GSK's ViiV touts 2-month HIV data as sister injection Cabenuva awaits FDA redemption

Health Canada based its approval on two phase 3 studies showing Cabenuva could match up to standard-of-care, daily, oral three-drug regimens at suppressing HIV. In the Atlas study, the drug successfully contained the virus in 92.5% of patients after 48 weeks, while 95.5% of those on a three-drug regimen had undetectable viral loads. In the Flair trial, the injectable’s 48-week virologic suppression rate hit 93.6%, as ViiV’s own therapy Triumeq (abacavir/dolutegravir/lamivudine) reached 93.3%. 

Despite its approval in Canada, Cabenuva's hopes of beating out daily standard-of-care, three-drug HIV regimens––at least in the U.S.––could have a long way to go. 

Not only is GSK chasing Gilead Sciences' market-leading HIV portfolio––including megablockbuster Biktarvy, which hit $4.74 billion in sales in 2019––it's also having to contend with the FDA, which has pushed back on Cabenuva's manufacturing. 

RELATED: No holiday gift for GSK: FDA sends long-acting HIV injectable back to work