Glaxo's HIV drug a step closer to regulatory submission

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.

MoneyWeek

Subscribe to MoneyWeek today and get your first six magazine issues absolutely FREE

Get 6 issues free

https://cdn.mos.cms.futurecdn.net/flexiimages/mw70aro6gl1676370748.jpg

Sign up to Money Morning

Don't miss the latest investment and personal finances news, market analysis, plus money-saving tips with our free twice-daily newsletter

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.

MoneyWeek is written by a team of experienced and award-winning journalists, plus expert columnists. As well as daily digital news and features, MoneyWeek also publishes a weekly magazine, covering investing and personal finance. From share tips, pensions, gold to practical investment tips - we provide a round-up to help you make money and keep it.