Janssen announces submission of new drug application to U.S. FDA for the first monthly, injectable, two drug regimen of rilpivirine and cabotegravir for treatment of HIV


29 April 2019 - If approved, the rilpivirine and cabotegravir regimen would be the first-ever long-acting injectable treatment for adults living with HIV.

The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that a new drug application to the U.S. FDA has been submitted by ViiV Healthcare for the investigational once-monthly, injectable, two-drug regimen of Janssen's rilpivirine and ViiV's cabotegravir for the treatment of HIV in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.

The submission is based on the ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal Phase 3 studies that included more than 1,100 patients from 16 countries. These studies demonstrated that the combination of rilpivirine and cabotegravir, injected monthly, was as effective as a standard of care, daily, oral three-drug regimen in maintaining viral suppression throughout the 48-week study period. These results were presented in March at the 2019 Conference on Retroviruses and Opportunistic Infections.

Read Janssen press release

Michael Wonder

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Michael Wonder