Glaxo's HIV drug a step closer to regulatory submission

published 4 October 2012

Pharmaceuticals behemoth GlaxoSmithKline said its joint venture company, Shionogi-ViiV Healthcare, has completed an initial clinical registration package for dolutegravir, its treatment for HIV patients.

Phase III data required for initial regulatory filings for dolutegravir to be used on adults infected with HIV are now in house. Data from the two phase III studies in treatment-experienced patients (VIKING-3 and SAILING) will be the subject of future presentations at scientific meetings, Glaxo revealed.

Together with previously disclosed data from the SPRING-2 and SINGLE studies, which were conducted on patients who previously had not been treated for HIV, the latest results support Shionogi-ViiV Healthcare's plans to commence global regulatory submissions for dolutegravir before the end of 2012.

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Dolutegravir is not yet approved as a treatment for HIV or any other indication anywhere in the world.

The Shionogi-ViiV Healthcare joint venture was established between Shionogi,the Japanese pharmaceutical firm, ViiV Healthcare, a global company with a sole focus on HIV established in 2009 by Glaxo and US peer Pfizer.

Dolutegravir is the joint venture's flagship development drug but the company is also developing another integrase inhibitor - drugs which interfere with the role the enzyme integrase plays in HIV replication - which is at an earlier stage of development.