U.S. FDA approves GlaxoSmithKline's HIV drug Tivicay
WASHINGTON (Reuters) - 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.
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.
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 stake.
an HIV joint venture between GSK, Pfizer Inc and Shionogi & Co Ltd in which
GSK is the largest shareholder, with a 76.5 percent stake.
Analysts on average expect sales of
the drug to reach about $900 million by 2017, according to six analysts polled
by Thomson Reuters.
the drug to reach about $900 million by 2017, according to six analysts polled
by Thomson Reuters.
Tivicay can be used to treat
infected adults who have been treated with other drugs or are new to treatment.
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 of
action.
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 of
action.
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.
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.
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.
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.
of the drug in children.
Last week the FDA approved Alere
Inc's HIV test which is designed to diagnose HIV infection earlier.
Inc's HIV test which is designed to diagnose HIV infection earlier.
(Reporting by Toni Clarke in
Washington and Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal and
Lisa Shumaker)
Washington and Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal and
Lisa Shumaker)
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3)Divorce, Breakup problem and To Re-unit
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8)to enlargement of manhood