CHMP recommends Triumeq for HIV-Viiv Healthcare
The EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Triumeq (dolutegravir/abacavir/lamivudine), from ViiV Healthcare, for the treatment of HIV infection in adults and adolescents aged 12 years and older and weighing at least 40kg. The opinion is based upon data from two pivotal studies: a Phase III study of dolutegravir (SINGLE), conducted with dolutegravir and abacavir/lamivudine as separate pills, and 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. A final decision by the EC is anticipated during the third quarter of 2014.