- ViiV Healthcare, specialist HIV company majority owned by GlaxoSmithKline (NYSE:GSK), with Pfizer <<NYSE:PFE>> and Shionogi as shareholders, announces the submission of a supplemental New Drug Application ((sNDA)) to the US FDA for the expanded use of Cabenuva (cabotegravir, rilpivirine).
- The application seeks to expand Cabenuva’s label to include every 2-months dosing for the treatment of HIV-1 infection in virologically suppressed adults on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
- Cabenuva is a complete long-acting regimen with two separate injectable medicines, ViiV Healthcare’s cabotegravir and Janssen Sciences Ireland's rilpivirine.
- The medication was approved by the FDA in January 2021 as a once monthly treatment for HIV-1 infection in virologically suppressed adults.
- The sNDA is based on results from the global phase IIIb ATLAS-2M study, which showed the antiviral activity and safety of Cabenuva administered every 2-months was non-inferior when compared to once monthly administration.