ViiV Healthcare applies for new injectable regimen approval
In January 2021 the US Food and Drug Administration (FDA) approved the use of the injectable HIV treatment, Cabenuva. Now ViiV Healthcare has filed an application to expand the product labelling to include bi-monthly dosing.
Data from the Phase III ATLAS-2M trial, which examined the safety and efficacy of the long-lasting injectable, showed that dosing every other month was non-inferior in efficacy to monthly dosing. This means that a person on this regimen would only need six injections a year.
Cabenuva is long-lasting injectable formula of cabotegravir and rilpivirine that forms a complete regimen for the treatment of HIV in adults.
This is the first injectable ARV therapy for HIV approved in the United States. A year earlier, Cabenuva and Vocabria were marketed in Canada, and were approved by the Committee on Medicines for Human Health (CHMP) for marketing authorisation for sale in the European Union.