Novo Nordisk Receives FDA Approval of Tresiba® (insulin degl
Dec 19, 2016 20:22:37 GMT -5
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Novo Nordisk Receives FDA Approval of Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL) for Use in Children and Adolescents With Diabetes
PR NewswireDecember 19, 2016
PLAINSBORO, N.J., Dec. 19, 2016 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL), a once-daily, long-acting basal insulin, to be used in children and adolescents with diabetes. Tresiba®, first approved by the FDA in September 2015, is now indicated to improve glycemic control in patients with type 1 and type 2 diabetes from the age of one through adulthood,1 making it the only basal insulin approved for both type 1 and type 2 diabetes in patients as young as 1 year old. Tresiba® is a long-acting insulin that is released over time, has a 25 hour half-life and has a consistently flat and stable profile at steady state.1
"We are seeing a rise in the number of children and adolescents with diabetes in the U.S., especially those with type 2, and are proud to support these patients by offering new and effective treatment options," said Todd Hobbs, M.D., U.S. chief medical officer, Novo Nordisk.2 "It can be challenging for children with type 1 diabetes and their parents to manage blood sugar levels and keep up with multiple injections throughout an already busy day. With this approval, they now have another option of a long-acting insulin that is dosed once daily."
Novo Nordisk submitted the supplemental New Drug Application (sNDA) based on the results of the BEGIN™ Young 1 trial, a multi-national, 26-week, phase 3b, randomized, controlled, open-label, parallel-group, treat-to-target non-inferiority trial with a 26-week extension. BEGIN™ Young 1 compared the efficacy and safety of Tresiba® administered once-daily compared with Levemir® (insulin detemir [rDNA origin] injection) administered once-daily or twice daily, both in combination with insulin aspart, a mealtime insulin, in children and adolescents with type 1 diabetes aged 1 to 17. The results showed that Tresiba® in combination with insulin aspart effectively improved glycemic control. The most common adverse events were infection, hypoglycemia and hyperglycemia.3 The use of Tresiba® in patients one year of age and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes.1
Novo Nordisk Receives FDA Approval of Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL) for Use in Children and Adolescents With Diabetes
PR NewswireDecember 19, 2016
PLAINSBORO, N.J., Dec. 19, 2016 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL), a once-daily, long-acting basal insulin, to be used in children and adolescents with diabetes. Tresiba®, first approved by the FDA in September 2015, is now indicated to improve glycemic control in patients with type 1 and type 2 diabetes from the age of one through adulthood,1 making it the only basal insulin approved for both type 1 and type 2 diabetes in patients as young as 1 year old. Tresiba® is a long-acting insulin that is released over time, has a 25 hour half-life and has a consistently flat and stable profile at steady state.1
"We are seeing a rise in the number of children and adolescents with diabetes in the U.S., especially those with type 2, and are proud to support these patients by offering new and effective treatment options," said Todd Hobbs, M.D., U.S. chief medical officer, Novo Nordisk.2 "It can be challenging for children with type 1 diabetes and their parents to manage blood sugar levels and keep up with multiple injections throughout an already busy day. With this approval, they now have another option of a long-acting insulin that is dosed once daily."
Novo Nordisk submitted the supplemental New Drug Application (sNDA) based on the results of the BEGIN™ Young 1 trial, a multi-national, 26-week, phase 3b, randomized, controlled, open-label, parallel-group, treat-to-target non-inferiority trial with a 26-week extension. BEGIN™ Young 1 compared the efficacy and safety of Tresiba® administered once-daily compared with Levemir® (insulin detemir [rDNA origin] injection) administered once-daily or twice daily, both in combination with insulin aspart, a mealtime insulin, in children and adolescents with type 1 diabetes aged 1 to 17. The results showed that Tresiba® in combination with insulin aspart effectively improved glycemic control. The most common adverse events were infection, hypoglycemia and hyperglycemia.3 The use of Tresiba® in patients one year of age and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes.1
