ViiV submits dolutegravir for approval to treat HIV in US, EU and Canada

The GlaxoSmithKline (GSK)/Pfizer HIV joint venture ViiV Healthcare has submitted its lead drug candidate dolutegravir for approval in the US, EU and Canadian markets.

The venture, which was established in 2009, has filed applications to the relevant regional authorities for use of the integrase inhibitor in the treatment of HIV infection in adults and adolescents.

“These regulatory submissions are an important step for ViiV Healthcare, representing our commitment as a company to bring new treatments to people living with HIV.” said John Pottage, MD, chief scientific and medical officer, ViiV.,“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 naïve and treatment-experienced patients with HIV.”

The submissions follow a successful phase III programme that demonstrated the drug was more effective than Gilead Sciences/Bristol-Myers Squibb's big-selling Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate), a fixed-dose triple therapy for HIV, which achieved nearly $900m in sales during the first quarter of 2012.

Further clinical trials have also demonstrated that a once-daily dose of dolutegravir is as effective as a twice-daily dose of raltegravir in treatment-naïve patients.

These favourable data have led analysts at JPMorgan Chase & Co to predict the drug could achieve a peak annual turnover of $5bn.

The Japanese pharma firm Shionogi will also be hoping the drug passes through the regulatory process, as it holds a 10 per cent stake in ViiV.

Shionogi used to be part of a joint venture with ViiV, but the terms were rewritten in October, 2012.

ViiV chairman David Redfern, commented at the time:"ViiV Healthcare and Shionogi believe that now is the right time to simplify and evolve their existing arrangement."