Posted by Michael Wonder on 29 Jul 2019
ViiV Healthcare submits regulatory application to European Medicines Agency for investigational cabotegravir to be used in combination with rilpivirine as the first monthly, injectable treatment for HIV
29 July 2019 - The marketing application is based on phase III ATLAS and FLAIR pivotal trials in which the once-monthly, injectable treatment regimen showed similar efficacy and safety to daily, 3-drug oral treatment.
ViiV Healthcare with Pfizer and Shionogi today announced the submission of a marketing authorisation application to the EMA 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 also includes data for cabotegravir oral tablets, intended for use as oral lead-in therapy prior to the commencement of injectable therapy.
