ViiV Healthcare has submitted a regulatory application to the European Medicines Agency (EMA) for investigational drug cabotegravir to be used in combination with Janssen’s Edurant (rilpivirine) as the first monthly, injectable treatment for HIV.
The indication is for infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or Edurant, and the application also includes data for cabotegravir oral tablets, intended for use as oral lead-in therapy prior to the commencement of injectable therapy.
The submission is based on the global ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal phase III studies, which found that the investigative combo, injected monthly, was as effective as a daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period.
Kimberly Smith, head of global medical research and strategy at ViiV Healthcare said that the submission “supports ViiV Healthcare’s commitment to developing new and innovative options for people living with HIV to manage their virus. We are proud to be at the forefront of this innovation for patients by potentially changing the frequency of therapy from 365 days per year to just 12.”
The FDA application also follows the recent submission of a New Drug Application (NDA) for the combination, as well as cabotegravir oral tablets to the US Food and Drug Administration (FDA) in April 2019.
Cabotegravir is an investigational integrase inhibitor currently in development by ViiV Healthcare for the treatment and prevention of HIV, and is not approved by regulatory authorities anywhere in the world.