Pfizer, GSK's Viiv Healthcare nabs FDA approval for 3-in-1 HIV drug
- Triumeq (abacavir/dolutegravir/lamivudine) is a three-in-one, oral, fixed-dose combo therapy for HIV developed by Viiv Healthcare, a specialist HIV company formed by GSK and Pfizer.
- This new drug is the first FDA-approved dolutegravir-based, fixed-dose combination. Its approval followed positive results from two phase III clinical trials.
- Triumeq is viewed as a new competitor to Gilead's Atripla (efavirenz/emtricitabane/tenofovir), which had revenues of $3.64 billion in 2013.
What really sets Viiv's three-in-one combo apart is its inclusion of dolutegravir, which was approved in the US in August 2013 and in the EU in January 2014.
Triumeq's clinical trial results are sure to put Gilead execs on notice. In a phase III, 96-week study comparing Triumeq and Atripla, 80% of participants using the dolutegravir-based regimen were virologically suppressed, compared with 72% of Atripla-treated participants -- an improvement of 11%. Many key opinion leaders in the field of HIV therapeutics are excited about the launch of this new treatment option, and Trimeq is expected to receive European approval soon.
- Pharma Times ViiV gets FDA green light for HIV triple combo