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LONDON (Alliance News) - GlaxoSmithKline PLC on Monday said ViiV Healthcare is seeking US Food & Drug Administration approval for the investigational, monthly, injectable, two-drug regimen of cabotegravir and Janssen Pharmaceutical's rilpivirine to treat HIV-1 infection in adults.
Pharmaceutical company ViiV Healthcare is a joint venture created by Glaxo and Pfizer Inc in 2009, with Shionogi Ltd taking a share in 2012. Janssen is part of the US's Johnson & Johnson.
The submission is based on the global antiretroviral therapy as long-acting suppression and first long-acting injectable regimen pivotal phase three studies that included more than 1,100 patients from 16 countries.
Glaxo said the study has 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.
"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," explained ViiV Healthcare Chief Executive Deborah Waterhouse.
"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," added John Pottage, chief scientific & medical officer of ViiV Healthcare.
Looking ahead ,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.
Glaxo shares were trading 0.4% higher on Monday at 1,567.00 pence each.
