December 18, 2012

ViiV Files Regulatory Applications for New Integrase Inhibitor Dolutegravir

ViiV Healthcare announced it has filed regulatory applications for the company’s investigational HIV integrase inhibitor dolutegravir in the United States, Canada and the European Union. The applications seek approval for the new drug to treat HIV among people 12 and older. ViiV has submitted its applications to the U.S. Food and Drug Administration (FDA), Health Canada and the European Medicines Agency.

The pharmaceutical company recently presented Phase III clinical trial data showing dolutegravir (S/GSK1349572) was effective at treating patients with multidrug resistance—specifically, resistance to the integrase inhibitors raltegravir and/or elvitegravir. The drug maintains a relatively low side effect profile, and only 3 percent of study participants discontinued because of adverse effects.

In a statement, ViiV’s chief scientific and medical officer John Pottage, MD, said, “We are encouraged by the comprehensive data package supporting dolutegravir, and believe that it has the potential to offer an important new option for the treatment of both naive and treatment-experienced patients with HIV.”

To read the ViiV release, click here.

Search: HIV, ViiV Healthcare, regulatory application, integrase inhibitor, dolutegravir, U.S. Food and Drug Administration, FDA, , Health Canada, European Medicines Agency, S/GSK1349572, raltegravir, elvitegravir, low side effect profile, John Pottage, treatment-naive, treatment-experienced.

Scroll down to comment on this story.