ViiV Healthcare has received the green light from US regulators for its HIV triple combination treatment Triumeq.
The joint venture owned by GlaxoSmithKline, Pfizer and Shionogi says the US Food and Drug Administration has approved Triumeq, which combines ViiV’s integrase inhibitor Tivicay (dolutegravir) with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine. The thumbs-up is based on data from two trials, most notably a Phase III study (called SINGLE) where at 96 weeks, 80% of participants on the dolutegravir-based regimen were virologically suppressed compared to 72% for those on Gilead Sciences’ triple combo Atripla (efavirenz/tenofovir/emtricitabine).
Dominique Limet, ViiV’s chief executive, said that “we are proud to announce this important milestone, marking the second new treatment to be approved in the US from our pipeline”. Tivicay got the go-ahead across the Atlantic in August 2013 and in Europe in January 2014.
An approval for Triumeq in Europe is likely very soon, given that the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive opinion for the triple combo at the end of June.