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中国药学(英文版) ›› 2015, Vol. 24 ›› Issue (10): 695-698.

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Information from US FDA

http://www.fda.com   

  1. http://www.fda.com
  • 收稿日期:2015-10-05 修回日期:2015-10-10 出版日期:2015-10-21 发布日期:2015-10-15

Information from US FDA

http://www.fda.com   

  1. http://www.fda.com
  • Received:2015-10-05 Revised:2015-10-10 Online:2015-10-21 Published:2015-10-15

摘要:

The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus. According to the Centers for Disease Control and Prevention, approximately 21 million people in the United States have been diagnosed with diabetes. Over time, diabetes increases the risk of serious health complications, including heart disease,blindness, nerve and kidney damage. Improvement in blood sugar control can reduce the risk of some of these long-term complications. "Long-acting insulins play an essential role in the treatment of patients with type-1 diabetes and in patients with type-2 diabetes with advanced disease," said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA remains committed to support the development of innovative therapies for the treatment of diabetes.”

Abstract:  

The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus. According to the Centers for Disease Control and Prevention, approximately 21 million people in the United States have been diagnosed with diabetes. Over time, diabetes increases the risk of serious health complications, including heart disease,blindness, nerve and kidney damage. Improvement in blood sugar control can reduce the risk of some of these long-term complications. "Long-acting insulins play an essential role in the treatment of patients with type-1 diabetes and in patients with type-2 diabetes with advanced disease," said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA remains committed to support the development of innovative therapies for the treatment of diabetes.”

Supporting: