ViiV Healthcare is seeking approval from the US Food and Drug Administration (FDA) for the investigational, monthly, injectable, two-drug regimen of cabotegravir and rilpivirine to treat HIV.
The company has submitted a new drug application (NDA) to the FDA for two-drug regimen to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.
Cabotegravir, which is ViiV Healthcare’s investigational integrase inhibitor (INI), is not approved by regulatory authorities anywhere in the world. It is being developed for the treatment and prevention of HIV.
Janssen’s Edurant (rilpivirine) is a once daily non-nucleoside reverse transcriptase inhibitor (NNRTI) developed to treat human immunodeficiency virus (HIV-1) infection in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35-kg with a viral load ≤ 100,000 HIV RNA copies/mL.
ViiV Healthcare CEO Deborah Waterhouse said: “The long-acting, once-monthly, injectable regimen of cabotegravir and rilpivirine 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.”
The application was submitted based on data from the global ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal phase III studies, which evaluated more than 1,100 patients from 16 countries.
The studies showed the combination of cabotegravir and rilpivirine, 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, said the company.
ViiV Healthcare and Janssen intend 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.
Under regulatory submission package to the FDA, ViiV Healthcare submitted a second NDA for an oral tablet formulation of cabotegravir, which would be taken as an oral lead-in with an already-approved, once-daily, oral tablet formulation of rilpivirine.
ViiV Healthcare chief scientific and medical officer Dr John Pottage said: “The ATLAS and FLAIR data support the efficacy and safety of this investigational two-drug regimen, and the fact that more than 85 percent of study participants said they preferred it to their prior, daily oral therapy suggests we are delivering a welcome option.”