ViiV Healthcare Ltd. said it has submitted a marketing application to the U.S. Food and Drug Administration for its single-tablet, two-drug regimen to treat HIV-1 infection.
U.K.-based ViiV Healthcare is majority-owned by GlaxoSmithKline PLC and counts Pfizer Inc. and Japan-based Shionogi & Co. Ltd. as its shareholders.
The tablet comprises dolutegravir, marketed as Tivicay by Viiv, and another HIV-1 treatment lamivudine.
ViiV Healthcare's application is based on two phase 3 studies, called Gemini-1 and Gemini-2, which showed that the regimen was just as effective as a three-drug combination among untreated HIV patients.
The company has also submitted a priority review voucher to the FDA that will reduce the duration of the therapy's regulatory review to six months, according to an Oct. 18 news release.
ViiV submitted a marketing authorization application to the European Medicines Agency in September and will initiate other global regulatory submissions in the coming months.