ViiV Healthcare Receives FDA Approval for HIV Drug Triumeq
ViiV Healthcare, a specialist HIV company of Pfizer, GlaxoSmithKline, and Shionogi, have received approval from the US Food and Drug Administration (FDA) for Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection. Triumeq is ViiV Healthcare's first dolutegravir-based fixed-dose combination of a single-pill regimen that combines the integrase strand transfer inhibitor dolutegravir, with the nucleoside reverse transcriptase inhibitors abacavir and lamivudine.
Dolutegravir was approved in the US in August 2013 and in Europe in January 2014 under the brand name Tivicay.The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion on the marketing authorization application (MAA) for Triumeq in June 2014. Regulatory applications are also being evaluated in other markets worldwide, including Australia, Brazil, and Canada.
ViiV Healthcare was established in November 2009 by GSK and Pfizer with a specific focus on HIV treatments.Shionogi joined as a shareholder in October 2012.