Reuters: Regulatory News: UPDATE 1-U.S. FDA approves GlaxoSmithKline's HIV drug Tivicay

Reuters: Regulatory News Reuters.com is your source for breaking news, business, financial and investing news, including personal finance and stocks. Reuters is the leading global provider of news, financial information and technology solutions to the world's media, financial institutions, businesses and individuals. // via fulltextrssfeed.com

The Best Way to Manage your Money. Start using Mint today to set a budget, track your goals and do more with your money. From our sponsors

UPDATE 1-U.S. FDA approves GlaxoSmithKline's HIV drug Tivicay Aug 12th 2013, 22:38 Mon Aug 12, 2013 6:38pm EDT WASHINGTON Aug 12 (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. Link this Share this Digg this Email Reprints

You are receiving this email because you subscribed to this feed at blogtrottr.com. If you no longer wish to receive these emails, you can unsubscribe from this feed, or manage all your subscriptions