Pharmaceutical Business review

Shionogi-ViiV to file HIV drug for approval

The phase III studies data include VIKING-3 and SAILING studies, which used dolutegravir in treatment of HIV patients who have already experienced treatment.

The two studies support the previously disclosed data from the SPRING-2 and SINGLE studies.

These additional study data are expected to support Shionogi-ViiV Healthcare’s plans to commence global regulatory submissions for dolutegravir before the end of 2012.

Dolutegravir has not received any approval as a drug to treat HIV or any other indication anywhere in the world.

VIKING-3, SAILING, SPRING-2 and SINGLE are all ongoing clinical studies in treatment-experienced adults with HIV-1 to assess the antiviral activity and safety of dolutegravir 50mg twice-daily in treatment-experienced adults with HIV-1.