Novo Nordisk, Inc. operates as a healthcare company that focuses on diabetes care. The company provides diabetes pharmaceuticals and insulin delivery systems. It also specializes in hemophilia care, growth hormone therapy, and hormone replacement therapy. The company was incorporated in 1982 and is headquartered in Princeton, New Jersey. It has a manufacturing facility in Clayton, North Carolina; and a research and development center in Seattle, Washington. Novo Nordisk, Inc. operates as a subsidiary of Novo Nordisk A/S.
100 College Road West
Princeton, NJ 08540
Founded in 1982
Novo Nordisk Launches Tresiba® (Insulin Degludec Injection 200 Units/mL) in the United States
Jan 26 16
Novo Nordisk announced the availability of its newest insulin, Tresiba® (insulin degludec injection), a once-daily, long-acting basal insulin, at pharmacies nationwide. Tresiba®, approved by the U.S. Food and Drug Administration (FDA) in September 2015, is indicated to improve glycemic control in adults with diabetes. Adults with diabetes who require insulin therapy often must plan their schedules to accommodate the need to take insulin at the same time every day. Tresiba® is a long-acting insulin that is released over time, lasts at least 42 hours after eight once-daily injections and has a consistently flat and steady profile at steady state. Tresiba® allows patients to dose at any time of day to accommodate their schedules. Patients who miss a dose of Tresiba® should take their medication upon discovering the missed dose as long as at least eight hours have elapsed between consecutive Tresiba® injections. Tresiba® is not recommended for the treatment of diabetic ketoacidosis and it is not known if Tresiba® is safe and effective in children under 18 years of age. Eligible patients with commercial insurance can use the Tresiba® Instant Savings Card to reduce co-pays to as low as $15 a month for up to 24 months. Novo Nordisk is working quickly to secure coverage for Tresiba® on health plans nationwide and has already secured Lowest Brand Co-pay status on the national formulary for CVS Caremark.
Novo Nordisk Receives FDA Approval for Tresiba® (insulin degludec injection) for Adults with Type 1 and Type 2 Diabetes
Sep 25 15
Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for Tresiba® (insulin degludec injection), a once-daily, long-acting basal insulin. Tresiba® is indicated for use alone, or in combination with oral antidiabetic medicines or bolus insulin, and is approved for glycemic control in adults with type 1 and type 2 diabetes. Tresiba® provides a long duration of action beyond 42 hours. While patients are encouraged to take their insulin at the same time each day, Tresiba® allows patients to dose at any time of the day. The approval is based on data from the BEGIN® clinical trial program and includes an interim analysis of DEVOTE, the cardiovascular outcomes trial for Tresiba®. The BEGIN® clinical trial program includes nine randomized, controlled, treat-to-target, open-label trials in patients with type 1 and type 2 diabetes from over 40 countries. The FDA concluded based on the provided data that Tresiba® improves glycemic control, achieving comparable A1C reductions (noninferiority) to FDA-approved comparators. The most common side effect in BEGIN® was hypoglycemia. Tresiba® will be available in the FlexTouch® pen, which has no push-button extension, and will be offered in two concentrations enabling maximum doses of 80 units and 160 units per single injection, respectively. Tresiba® also offers other patient benefits such as eight weeks of in-use time at room temperature. Indications and Usage: Tresiba® (insulin degludec injection) is indicated to improve glycemic control in adults with diabetes mellitus. Limitations of Use: Tresiba® is not recommended for treating diabetic ketoacidosis. Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients. Warnings and PrecautionsNever Share a Tresiba® FlexTouch® Pen Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens. Monitor blood glucose in all patients treated with insulin. Changes in insulin may affect glycemic control. These changes should be made cautiously and under medical supervision. Adjustments in concomitant oral anti-diabetic treatment may be needed. Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening. Increase monitoring with changes to: insulin dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment. Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors, always instruct patients to check the insulin label before each injection. Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Tresiba®. As with all insulins, Tresiba® use can lead to life-threatening hypokalemia, which then may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated. Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Tresiba®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered. Adverse reactions commonly associated with Tresiba® are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain. Drug Interactions: Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs and symptoms of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine).
Novo Nordisk Announces the Latest Interim Data from the Guardian 2 Extension Trial
Jun 24 15
At the International Society on Thrombosis and Haemostasis 2015 Congress, Novo Nordisk announced the latest interim data from the guardian 2 extension trial, which showed that in a phase 3 trial, Zonovate, provided long-term efficacy and safety in the prophylaxis and treatment of bleeds in people with severe haemophilia A. The pivotal guardian clinical programme was one of the largest and most comprehensive preregistration clinical trial programmes in haemophilia A, with more than 210 patients with severe haemophilia A treated. Interim data collected through December 31, 2013 from 451.6 patient-years on Zonovate show results consistent with previous reports: The overall estimated median annual bleeding rate achieved during the preventive regimen with Zonovate was 1.56. During the preventive regimen, 90% of all bleeding episodes were successfully treated with one or two infusions of Zonovate. Guardian 2 is a large, multinational extension trial of Zonovate in previously treated patients with haemophilia A from 19 countries who had been enrolled in the pivotal guardian™1 and guardian 3 trials. Patients received Zonovate in a prophylactic regimen and to treat breakthrough bleeds. These findings now comprise more than four years of data and more than 450 patient years. No inhibitors to factor VIII were detected and no safety issues were identified, supporting the findings from guardian 1 and 3, demonstrating no confirmed inhibitor development in 213 previously treated patients. The most common adverse reactions seen in the study were injection-site reactions, increased hepatic enzymes and fever.