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Dolutegravir: FDA Onayı Alan Antiretroviral İlaçlara Bir İntegraz İnhibitörü Daha Eklendi

U.S. FDA approves GlaxoSmithKline’s HIV drug Tivicay


WASHINGTON | Mon Aug 12, 2013 6:40pm EDT

(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.

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 stake.

Analysts on average expect sales of 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.

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.

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 earlier.

(Reporting by Toni Clarke in Washington and Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal and Lisa Shumaker)