Novo Nordisk Receives FDA Approval for Xultophy® 100/3.6

On Nov 23, 2016

Plainsboro-based Novo Nordisk, a world leader in diabetes care, today announced that the US 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 US 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). The maximum dose of 50 units of Xultophy® 100/3.6 corresponds to 50 units of insulin degludec and 1.8 mg of liraglutide.

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