ViiV Healthcare announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending marketing authorisation for Triumeq®.
The single-tablet regime is for the treatment of HIV infection in adults and adolescents aged 12 years and older and weighing at least 40kg.
ViiV Healthcare announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending marketing authorisation for Triumeq®.
The single-tablet regime is for the treatment of HIV infection in adults and adolescents aged 12 years and older and weighing at least 40kg.
“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.”
The CHMP positive opinion is based upon data from two pivotal studies:
- the phase III study of dolutegravir (SINGLE), conducted with dolutegravir and abacavir/lamivudine as separate pills; and(1)
- a separate bioequivalence study of the fixed-dose combination of dolutegravir/abacavir/lamivudine when taken as a single tablet compared to the administration of dolutegravir and abacavir/lamivudine as separate pills.(2)
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission (EC), but does not always result in marketing authorisation. A final decision by the EC is anticipated during the third quarter of 2014.
References
- Walmsley SL et al; for the SINGLE Investigators. Dolutegravir plus abacavir–lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013;369(19):1807–18.
- Weller S et al. Bioequivalence of a Dolutegravir, Abacavir and Lamivudine Fixed-Dose Combination Tablet and the Effect of Food. JAIDS. 2014 [Epub ahead of print].
