9 July 2019 - The long-acting injectable regimen has been granted priority review status by the FDA, with a target approval date set for 29 December 2019.
In April 2019, ViiV Healthcare submitted a new drug application to the US FDA for the two-drug regimen of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.
If approved, the regimen would be the first-ever long-acting, injectable therapy for the treatment of HIV.