ViiV file 572-trii fixed dose combination in the US: positive opinion to approve dolutegravir in the EU

ViiV press statements

On 22 October 2013, ViiV Healthcare submitted a new drug application to the US FDA for a single tablet combination of dolutegravir, abacavir and 3TC. [1]

EU submission for the combination (developed as 572-trii) is expected to follow in the next few months.

ViiV is responsible for producing all three drugs, although US patents for both 3TC and abacavir have now expired for single formulations. In the UK, generic 3TC is already available and abacavir is due to come off patent in 2014. [2]

Dolutegravir was approved in the US in August 2013 (brandname Tivicay). [3] EU approval is expected within the next two months, following a positive opinion recommending authorisations bt the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 22 November 2013. [4]


  1. ViiV Healthcare press statement. ViiV Healthcare announces US regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV. (22 October 2013).
  2. GSK Annual Report, 2006.
  3. Dolutegravir approved in the US. HTB September/October 2013.
  4. ViiV press statement. Tivicay (dolutegravir) receives positive CHMP opinion in Europe for the treatment of HIV. (22 November 2013).®-dolutegravir-receives-positive-chmp-opinion-in-europe-for-the-treatment-of-hiv.aspx

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