Viiv's HIV combo drug recommended for approval by EMA advisers
- The Committee for Medicinal Products for Human Use (CHMP) has recommended Triumeq (dolutegravir/abacavir/lamiduvine) for approval for treatment of HIV in patients aged 12 and older.
- Viiv is a company focused on developing HIV therapies. It is a joint venture between GSK, Pfizer and Shionogi in 2009
- Approval is based on two pivotal phase III trials.
Triumeq was approved for use in patients who are either antiretroviral naïve or HIV-positive, but without any evidence of resistance to abacavir, lamiduvine or dolutegravir. One of the pivotal studies of Triumeq evaluated the efficacy of taking dolutegravir and abacavir/lamivudine as separate pills. The other trial was a bioequivalence study of the two-tablet combo taken with separate dolutegravir versus the Triumeq fixed-dose combo. Results confirmed efficacy and bioequivalence.
Once this drug is introduced into the market, it will become a competitor to the first-in-class, three-in-one, fixed-dose, HIV medication, Atripla (efavirenz/emtricitabine/tenofovir), manufactured by Gilead.
- Seeking Alpha CHMP recommends EMA approval for Triumeq
- The Pharma Letter Six new drugs recommended for approval by EMA’s CHMP