ViiV Healthcare Seeks FDA Approval For Two-drug To Treat HIV-1 Infection
(RTTNews) - ViiV Healthcare, a joint venture between GlaxoSmithKline (GSK.L, GSK) and Pfizer Inc. (PFE), has submitted a New Drug Application to the US Food and Drug Administration seeking approval for an investigational, monthly, injectable, two-drug regimen of Rilpivirine and Cabotegravir for the treatment of HIV.
In pivotal phase III studies, dubbed ATLAS and FLAIR, the combination of Janssen's Rilpivirine and ViiV's Cabotegravir injected monthly, was as effective as a standard of care, daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period.
ViiV Healthcare and Janssen 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.
As part of the regulatory submission package to the FDA, a second NDA was submitted for an oral tablet formulation of Cabotegravir that would be taken once-daily as an oral lead-in with the already-approved oral tablet formulation of Rilpivirine (marketed by Janssen as EDURANT).