Dive Brief:
- 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.
Dive Insight:
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.