FDA Approves NDA For Xultophy 100/3.6 for Type 2 Diabetes

The FDA has approved the new drug application for Novo Nordisk’s Xultophy 100/3.6 as an adjunct to diet and exercise in adults with type 2 diabetes. The once-daily, single injection is designed to improve glycemic control inadequately treated on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily).

Xultophy 100/3.6, the approved brand name for IDegLira in the United States, is a fixed combination of long-acting insulin degludec (Tresiba) and the GLP-1 analogue liraglutide (Victoza). It can be taken at the same time each day with or without food and will be available for injection in a prefilled pen.

The approval follows phase 3 trials that involved 1,393 study participants, according to a statement from Novo Nordisk. In one of the published trials, Xultophy 100/3 reduced HbA1C levels from a baseline of 8.4% in the Xultophy group and a baseline of 8.2% in a comparatory glargine group by −1.81% and −1.13% respectively, which was statistically significant, according to the study researchers.¹

Xultophy 100/3.6 will be available in the United States in 2017.

The approval was announced on the same day as Sanofi’s combination product, Soliqua 100/33 was approved.

Reference

Lingvay I, Manghi FP, Garcia-Hernandez P, et al. Effet of insulin gargine up-titration vs. insulin deguldec/liraglutide on glycated hemoglobin levels in patients with uncontrolled type 2 diabetes: Th DUAL V Randomized Clinail Trial. JAMA. 2016; 315(9):898-907.