ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline PLC (LON:GSK), with Pfizer Inc. and Shionogi Limited as shareholders, today submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for the investigational, monthly, injectable, two-drug regimen of ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.
The submission is based on the global ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal phase III studies that included more than 1,100 patients from 16 countries and demonstrated 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. These results were presented in March at the 2019 Conference on Retroviruses and Opportunistic Infections.
Deborah Waterhouse, CEO of ViiV Healthcare, 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. ViiV Healthcare is proud to be at the forefront of this innovation in HIV treatment and we look forward to working with the FDA to provide people living with HIV in the US this novel option.”
John C. Pottage, Jr., M.D., Chief Scientific and Medical Officer of ViiV Healthcare, commented: “Our focus on developing innovative new HIV treatments, including long-acting injectable therapies, supports our goal of giving people living with HIV more options for managing the virus. 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. If approved, people receiving the monthly injectable regimen of cabotegravir and rilpivirine will reduce the number of days they have to take treatment from 365 to 12 per year.”
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, ViiV Healthcare submitted a second NDA for an oral tablet formulation of cabotegravir that would be taken as an oral lead-in with an already-approved, once-daily, oral tablet formulation of rilpivirine (marketed by Janssen as EDURANT®).
The ATLAS and FLAIR studies are part of ViiV Healthcare’s innovative clinical trial programme for two-drug regimens.
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