November 18, 2013
ViiV Submits Single-Pill Combo of Tivicay and Epzicom to FDA
ViiV Healthcare has submitted an application to the U.S. Food & Drug Administration for approval of a single-tablet antiretroviral (ARV) regimen to treat HIV that combines Tivicay (dolutegravir) and Epzicom (abacavir/lamivudine). If approved, the drug, which is sometimes referred to as “Trii,” would join Atripla, Stribild and Complera in the highly competitive field of single-tablet regimen players. The submission comes on the heels of Tivicay’s August 2013 FDA approval for use in combination with other ARVs.
“People living with HIV and their doctors seek to use appropriate treatment options for the individual, while also trying to minimize the number of pills required for effective and acceptable antiretroviral treatment,” John Pottage, MD, chief medical officer of ViiV Healthcare, said in a release. “This submission aims to make a complete Tivicay-based regimen available for the first time in a single once-daily pill.”
In the near future, ViiV also plans to submit an application in Europe to the Marketing Authorisation Application.
ViiV’s American submission is based on data from one Phase III study and is supported by three other Phase III/IIIb studies that evaluated the safety and efficacy of the drug regimen. The submission also includes data comparing the equivalence between the single- and the double-tablet regimen in how the body processes the three drugs. There is also an ongoing Phase IIIb/IV study of the single-tablet regimen among treatment-naive women with HIV.
To read the ViiV announcement, click here.
Search: ViiV Healthcare, Tivicay, dolutegravir, Epzicom, abacavir, lamivudine, Atripla, Stribild, Complera, U.S. Food & Drug Administration, Marketing Authorisation Application, John Pottage.
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