ViiV files for EU approval for cabotegravir plus rilpivirine

A marketing authorization application (MAA) has been filed with the European Medicines Agency for the investigational, once-monthly, injectable cabotegravir, which will be used in combination with Janssen’s once-monthly, injectable rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.

The application, filed by ViiV Healthcare, which is majority-owned by GlaxoSmithKline (LSE: GSK), also includes data for cabotegravir oral tablets, intended for use as oral lead-in therapy prior to the commencement of injectable therapy.

“ViiV Healthcare is proud to be sending a regulatory submission to the EMA for what will be a first-of-its-kind treatment. If approved, this long-acting, 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, 3-drug regimen taken every day. We are excited to be one step closer to delivering this long-acting therapy to patients in Europe,” noted ViiV chief executive Deborah Waterhouse.