ViiV Healthcare announced Monday the submission of a filing to the FDA seeking approval of a monthly, injectable, two-drug regimen combining the integrase inhibitor cabotegravir with Johnson & Johnson's non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to either drug. ViiV noted that if authorised, cabotegravir and Edurant would be "the first-ever long-acting, injectable treatment regimen for adults living with HIV."
Deborah Waterhouse, CEO of ViiV, said the long-acting regimen "has the potential to give people living with HIV one month between doses with similar safety and efficacy as today’s standard of care – an oral three-drug regimen that has to be taken every day." ViiV and Johnson & Johnson's Janssen unit plan to submit regulatory applications for the two-drug regimen of cabotegravir and rilpivirine to the European Medicines Agency, Health Canada and other global agencies in the coming months.
The submission to the FDA was supported by data from the Phase III ATLAS and FLAIR trials, which involved more than 1100 adults with virologically suppressed HIV. Results presented last month at the annual Conference on Retroviruses and Opportunistic Infections (CROI) showed that in the two studies, the combination of cabotegravir and Edurant given once every four weeks exhibiting non-inferiority to an oral, three-drug combination taken daily in maintaining viral suppression through 48 weeks.
ViiV and Johnson & Johnson are developing the combination of cabotegravir and Edurant under the terms of a 2016 partnership. GlaxoSmithKline, which holds a majority stake in ViiV alongside minority investors Pfizer and Shionogi, previously identified cabotegravir as one of as many as 20 investigational assets that could be submitted for regulatory approval by 2020.
Meanwhile, ViiV said Monday that it also submitted a separate FDA filing seeking authorisation for an oral formulation of cabotegravir that would be used as a lead-in with the previously approved oral formulation of Edurant. For related analysis, see ViewPoints: ViiV's monthly injectable vying for a seat at the HIV table.
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