ViiV Healthcare announced on 27 June that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Triumeq.
Triumeq is a fixed-dose combination containing dolutegravir, abacavir and lamivudine. All three drugs are singularly approved for the treatment of HIV in Australia, the US and Europe and other parts of the world; abacavir and lamivudine are also available in the duel-dose combination, Kivexa. Many people are taking these individual drugs together, and the availability of a coformulation of all three into a single pill would make taking this combination easier and less expensive.
The approval and availability of Triumeq would offer people living with HIV the first ‘0ne pill once a day’ single tablet without food requirements or restrictions.
"Today's positive opinion takes us a step closer to bringing physicians and people living with HIV a dolutegravir-based regimen that can be taken once-daily as a single-tablet," said Dr John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare. "This opinion supports the potential of dolutegravir-based regimens, as well as the importance of our ongoing research into additional single-tablet treatment options.”
An application for the licensing of Triumeq is with the Therapeutic Goods Administration (the TGA is Australia's regulatory agency for medical drugs and devices).