ViiV Healthcare Receives FDA Approval of HIV Drug Tivicay

ViiV Healthcare, a specialist HIV company of GlaxoSmithKline (GSK), Pfizer, and Shionogi, has received FDA approval for Tivicay (dolutegravir) 50-mg tablets. Tivicay is an integrase inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12-years and older weighing at least 40 kg (approx. 88 lbs).

ViiV Healthcare was established in November 2009 by GlaxoSmithKline and Pfizer to focus on developing treatments for HIV. The Japanese pharmaceutical company Shionogi joined as a 10% shareholder in October 2012 following a long-term collaboration on the joint development of several integrate inhibitors. ViiV Healthcare has a current portfolio of 11 HIV treatments, which generated 2012 sales of £1.4 billion ($2.2 billion). 

Tivicay is the first new treatment delivered by ViiV Healthcare. ViiV Healthcare also submitted a marketing authorization application for dolutegravir to the EMA in December 2012. Regulatory applications are also being evaluated in other markets worldwide, including Canada, Australia, and Brazil. Submission of regulatory files to support a fixed-dose combination of Tivicay and abacavir/lamivudine is anticipated in 2013.