GlaxoSmithKline and ViiV Healthcare apply for approval of new HIV regimen

GlaxoSmithKline and its specialist HIV affiliate ViiV Healthcare have filed for regulatory approval of an innovative new combination regimen for the treatment of HIV-1.

Regulatory submissions have been filed with the European Medicines Agency and US Food and Drug Administration for a single-tablet, two-drug regimen of ViiV Healthcare's dolutegravir and Janssen's rilpivirine for the maintenance treatment of HIV-1 infections.

This new regimen represents the first HIV maintenance regimen to comprise only two medicines, and has not yet been approved anywhere in the world.

Data from the SWORD clinical study programme, which involved more than 1,000 patients, showed the benefits of this regimen among patients who previously achieved viral suppression on a three or four-drug antiretroviral regimen.

Deborah Waterhouse, chief executive officer of ViiV Healthcare, said: "We look forward to working with regulatory authorities to bring this new single tablet, two-drug regimen to appropriate people living with HIV."

ViiV Healthcare is majority-owned by GlaxoSmithKline, with Pfizer and Shionogi acting as shareholders.

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