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FDA Approves Xultophy 100/3.6

Novo Nordisk Receives FDA Approval for Xultophy 100/3.6 (insulin degludec and liraglutide injection) for Type 2 Diabetes

PLAINSBORO, N.J., Nov. 21, 2016 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application for Xultophy 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection). Xultophy 100/3.6 is a once-daily, combination of Tresiba (insulin degludec injection) and Victoza (liraglutide) injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8 mg of liraglutide daily.1 Xultophy 100/3.6 enters into a new class of diabetes treatments that combine a basal insulin and a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in a single, once-daily injection.

"Novo Nordisk is committed to discovering and developing new medicines, like Xultophy 100/3.6, that may make a difference in the way some adults with type 2 diabetes manage their diabetes and achieve their treatment goals," said Jakob Riis, executive vice president and head of North America Operations, Novo Nordisk A/S. "Combining Tresiba and Victoza into a single injection will offer patients a new option that may help control their blood sugar. We look forward to making Xultophy® 100/3.6 available to adults with type 2 diabetes in the first half of 2017."

The approval of Xultophy 100/3.6 is based on efficacy and safety data from the DUAL™ (Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes) clinical development program. In three DUAL™ trials involving 1,393 adults with type 2 diabetes, patients who were inadequately controlled on liraglutide or basal insulin therapy and switched to Xultophy 100/3.6 achieved reductions in A1C.2,3 For adults uncontrolled on basal insulin, Xultophy 100/3.6 demonstrated significant reductions in A1C from baseline of 1.67% and 1.94%.2,4 The most common adverse events seen during the DUAL™ clinical development program included nasopharyngitis, headache, nausea, diarrhea, increased lipase, and upper respiratory tract infection.2,4

Novo Nordisk expects to launch Xultophy® 100/3.6 (insulin degludec and liraglutide injection) in the U.S. in the first half of 2017. Novo Nordisk will work diligently to secure access for Xultophy 100/3.6 on health plans nationwide and is committed to ensuring that Xultophy 100/3.6 is accessible and affordable for all appropriate patients. Novo Nordisk will also offer a savings card that will allow eligible patients with commercial insurance to reduce their co-pay.

"I am excited for this new class of type 2 diabetes medication that can offer patients another treatment option to help them reach their goals," said Professor John Buse, M.D., University of North Carolina School of Medicine, Chapel Hill, NC, and principal investigator for DUAL™ II. According to Buse, in the clinical development program, Xultophy® 100/3.6 showed improved glycemic control in patients who were uncontrolled on either liraglutide or basal insulin therapy.

Xultophy 100/3.6 is administered as a once-daily injection from a prefilled pen and can be taken with or without food. Each Xultophy 100/3.6 dosage unit contains one unit of insulin degludec and 0.036 mg of liraglutide.1 The starting dose of Xultophy 100/3.6 is 16 units (16 units insulin degludec and 0.58 mg liraglutide).1 The maximum dose of 50 units of Xultophy 100/3.6 corresponds to 50 units of insulin degludec and 1.8 mg of liraglutide.1

About Diabetes

In the United States, more than 29 million people are affected by diabetes.5 Type 2 diabetes accounts for 90 to 95 percent of all diabetes cases.5 Diabetes is emerging as one of the most serious health problems of our time; the number of Americans with diabetes has quadrupled over the past 30 years.6

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 41,600 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk-us.com or follow us on Twitter: @novonordiskus.

References

  1. Xultophy 100/3.6 [package insert]. Plainsboro, NJ: Novo Nordisk Inc; November 2016.
  2. Buse JB, Vilsbøll T, Thurman J, et al. Contribution of Liraglutide in the Fixed-Ratio Combination of Insulin Degludec and Liraglutide (IDegLira). Diabetes Care. 2014;37:2926–2933.
  3. Linjawi S, Bode BW, Chaykin LB, et al. Efficacy and safety of IDegLira (combination of insulin degludec + liraglutide), in insulin-naïve patients with type 2 diabetes uncontrolled on GLP-1 receptor agonist (GLP-1RA) therapy. Diabetologia. 2015;58(suppl 1):S401-S402.
  4. Lingvay I, Perez Manghi FC, García-Hernández P, et al. Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients With Uncontrolled Type 2 Diabetes: The DUAL V Randomized Clinical Trial. JAMA. 2016;315(9):898-907.
  5. Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2014. CDC website. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Accessed November 16, 2016.
  6. Centers for Disease Control and Prevention. Number (in Millions) of Civilian, Noninstitutionalized Adults with Diagnosed Diabetes, United States, 1980–2014. CDC website. http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm. Accessed November 16, 2016.

Tresiba®, Victoza®, and Xultophy® 100/3.6 are registered trademarks and DUAL™ is a trademark of Novo Nordisk A/S.

SOURCE Novo Nordisk

Posted: November 2016

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