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ViiV Healthcare makes regulatory submissions for HIV-1 treatment in US, EU

ViiV Healthcare made regulatory submissions to the European Medicines Agency and the U.S. Food and Drug Administration for a single-tablet, two-drug regimen of ViiV's drug Tivicay and Janssen Sciences Ireland UC's drug Edurant for the maintenance treatment of HIV-1 infection.

The submissions are based on studies that included patients who previously achieved viral suppression on a three- or four-drug antiretroviral regimen.

ViiV also submitted a priority review voucher to the FDA along with the new drug application for the two-drug regimen. The anticipated target action date is six months after receipt of the application.

The $130 million cost of the voucher will be reported as research and development expense in GlaxoSmithKline's second-quarter adjusted results.

ViiV is a global specialist HIV company majority owned by GlaxoSmithKline PLC, Pfizer Inc. and Shionogi & Co. Ltd. as shareholders. Janssen Sciences Ireland UC is a unit of Johnson & Johnson-owned Janssen Pharmaceutical Co.