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ViiV Healthcare submits NDA for two-drug HIV regimen

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ViiV Healthcare announced today that it has submitted a new drug application to the FDA seeking regulatory approval of a single-tablet, two-drug regimen containing dolutegravir and lamivudine for the treatment of HIV.

The application is based on data from two phase 3 trials showing that the once-daily regimen is noninferior to a standard three-drug regimen in treatment-naive patients with HIV.

ViiV also submitted a priority review voucher for the regimen and expects an FDA decision in 6 months. If approved, it would become the second two-drug HIV regimen available in the United States following the approval of ViiV’s Juluca last November.

“This regulatory submission is the next step in the two-drug regimen journey and reinforces our belief that many patients can control their disease with two drugs instead of three or more,” ViiV CEO Deborah Waterhouse said in a statement.