ViiV Healthcare Ltd. announced Monday that the U.S. Food and Drug Administration (FDA) has approved Tivicay (dolutegravir) 50-mg tablets as a treatment for HIV-1 in adults and children aged 12 years and older weighing at least 40 kg. Tivicay is an integrase inhibitor indicated for use in combination with other antiretroviral agents for the treatment.
ViiV Healthcare is a global specialist HIV company established in November 2009 by drug giants GlaxoSmithKline (GSK) and Pfizer, Inc. (PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi & Co., Ltd. joined as a 10 percent shareholder in October 2012. Shionogi is about 77 percent owned by GlaxoSmithKline.
Tivicay is the first new treatment delivered by ViiV Healthcare, and will be available in pharmacies by the end of the month. Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs.
"Today's approval shows that our singular focus on HIV can deliver important new medicines, maintaining our absolute commitment to the HIV/AIDS global response," said Dr Dominique Limet, CEO of ViiV Healthcare.
ViiV Healthcare submitted the New Drug Application (NDA) on December 17, 2012 to the US FDA for dolutegravir as the treatment of HIV infection in adults and adolescents. Later in February 2013, the FDA announced that it would fast track dolutegravir's approval process.
A priority review designation is granted to drugs that, if approved, have the potential to offer significant improvement compared to marketed products or provide a treatment where no adequate therapy exists. The FDA had assigned dolutegravir a Prescription Drug User Fee Act (PDUFA) target date of August 17, 2013.
The FDA approval was primarily based on safety and efficacy data submitted from four pivotal Phase III clinical trials that treated 2,557 adults with HIV across the treatment spectrum, from therapy naïve to salvage patients. It also included data in children aged 12 years and older.
Depending on the trial, participants were randomly assigned to receive Tivicay or Isentress (raltegravir), each in combination with other antiretroviral drugs, or Atripla, a fixed-dose combination of efavirenz, emtricitabine and tenofovir. The results from the four trials showed Tivicay-containing regimens were effective in reducing viral loads.
The company noted that Tivicay was used without a pharmacokinetic boosting agent.
About 50,000 Americans become infected with HIV each year and about 15,500 died from the disease in 2010, according to the Centers for Disease Control and Prevention.
ViiV Healthcare has also submitted a Marketing Authorization Application (MAA) for dolutegravir to the European Medicines Agency (EMA) on December 17, 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.
PFE closed Monday's regular trading session at $29.19, down $0.02 or 0.07% on a volume of 19.48 million shares, and GSK closed at $51.30, down $0.21 or 0.41% on a volume of 1.46 million shares.
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