ViiV Healthcare has submitted a new drug application to the US Food and Drug Administration (FDA) for the first ever monthly, injectable, two-drug regimen of cabotegravir and Edurant (rilpivirine) for treatment of HIV.
If approved, the combination would be the first-ever long-acting, injectable treatment regimen for adults living with HIV.
The submission is for patients whose viral load is suppressed and who are not resistant to cabotegravir or Edurant.
It's based on the global ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal Phase III studies which included more than 1,100 patients from 16 countries and demonstrated that the combination, injected monthly, was as effective as the current standard of care which is a daily, oral, three-drug regimen.
The combination of “cabotegravir and Edurant 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”, said Deborah Waterhouse, chief executive of ViiV Healthcare.
The company plans to submit regulatory applications for the two-drug regimen to the European Medicines Agency, Health Canada and other global agencies in the coming months.