WASHINGTON Aug 12 The U.S. Food and Drug
Administration said on Monday it has approved GlaxoSmithKline
Plc's drug Tivicay to treat the most common strain of
HIV, the virus that causes AIDS.
The once-daily drug, known generically as dolutegravir,
belongs to a novel class known as integrase inhibitors that
block the virus from entering cells.
Tivicay is owned by ViiV Healthcare, an HIV joint venture
between GSK, Pfizer Inc and Shionogi & Co Ltd
in which GSK is the largest shareholder, with a 76.5 percent
Analysts on average expect sales of the drug to reach about
$900 million by 2017, according to six analysts polled by
Tivicay can be used to treat infected adults who have been
treated with other drugs or are new to treatment.
The FDA also approved the drug for use in children aged 12
years and over, who weigh at least 40 kg (88 lbs) and who have
not received treatment with a drug that has the same mechanism
About 50,000 people in the United States are infected with
HIV each year and about 15,500 died in 2010, according to the
Centers for Disease Control and Prevention.
Common side effects of Tivicay in clinical trials included
insomnia and headache. Serious side effects included allergic
reactions and abnormal liver function in patients who were also
infected with hepatitis B or C.
Patients received either Tivicay or Merck & Co's
Isentress in combination with other HIV drugs; or they received
Atripla, a fixed-dose combination of three HIV drugs made by
Gilead Sciences Inc.
A fifth trial evaluated the safety of the drug in children.
Last week the FDA approved Alere Inc's HIV test
which is designed to diagnose HIV infection