ViiV Healthcare Receives EU Advisory Committee OK for HIV Combination TherapyBy
ViiV Healthcare, a specialist HIV company formed by GlaxoSmithKline, Pfizer, and Shionogi, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorization for Triumeq (dolutegravir/abacavir/lamivudine) for the treatment of HIV infection in adults and adolescents aged 12 years and older and weighing at least 40 kg. Triumeq is not currently approved in any country and is an investigational once-daily single tablet dolutegravir-based regimen, containing the integrase inhibitor dolutegravir, which was approved by the EMA in January 2014 under the brand name Tivicay.
A CHMP positive opinion is one of the final steps before marketing authorization is granted by the European Commission, but does not always result in marketing authorization. A final decision by the EC is anticipated during the third quarter of 2014.
A new drug application (NDA) for abacavir/dolutegravir/lamivudine was submitted to the US Food and Drug Administration in October 2013, and it is currently under review. The regulatory submission and review processes have also been initiated in Canada, Australia, Brazil, and Japan.
ViiV Healthcare was established in November 2009 by GlaxoSmithKline and Pfizer. Shionogi joined as a 10% shareholder in October 2012.