- The European Committee for Medicinal Products for Human Use (CHMP) recommended approval of ViiV Healthcare's Triumeq (dolutegravir/abacavir/lamiduvine) for the treatment of HIV on June 30. It has now received marketing authorization from the European Commission. ViiV is a joint venture by Pfizer and GlaxoSmithKline.
- Triumeq was approved by the FDA in late August. All approvals so far have been based on results from two phase III trials.
- Approval comes with the standard warning that abacavir should not be administered to patients known to carry the HLA-B 5701 allele and that all patients should be tested before initiating Triumeq therapy.
Now that Triumeq has been approved for use in adults and adolescents 12 and older on both sides of the Atlantic, what remains to be seen is the, oral, fixed-dose 3-in-1 combo's capacity to penetrate the market.
Triumeq is a clear competitor to Gilead and Bristol-Myers Squibb's Atripla (efavirenz/emtricitabane/tenofovir), which had $3.64 billion in revenues in 2013. What sets Triumeq apart from that therapy -- and has the medical community excited -- is its inclusion of dolutegravir, an integrase inhibitor that was approved in January in the EU and last year in the US.