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Xultophy Approval History

Reviewed on Nov 21, 2016 by J.Stewart BPharm.

  • FDA approved: Yes (First approved November 21st, 2016)
  • Brand name: Xultophy
  • Generic name: insulin degludec and liraglutide
  • Dosage form: Injection
  • Previous name: IDegLira
  • Company: Novo Nordisk
  • Treatment for: Diabetes, Type 2

Xultophy 100/3.6 (insulin degludec and liraglutide) is a fixed-ratio combination of the long-acting basal insulin analog, insulin degludec (Tresiba), and the a glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Victoza), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

FDA approval of Xultophy 100/3.6 was based on efficacy and safety data from three Phase 3 clinical trials involving 1,393 adults with type 2 diabetes. Results showed that patients who were inadequately controlled on liraglutide, basal insulin, or insulin glargine, all achieved reductions in A1C after conversion to Xultophy therapy.

Xultophy 100/3.6 is administered subcutaneously in the thigh, upper arm or abdomen via a pre-filled, pen injector once daily at same time each day, with or without food. Common side effects include stuffy or runny nose, sore throat, upper respiratory tract infection, increased blood levels of lipase, nausea, diarrhea, and headache.

Development History and FDA Approval Process for Xultophy

Nov 21, 2016Approval Novo Nordisk Receives FDA Approval for Xultophy 100/3.6 (insulin degludec and liraglutide injection) for Type 2 Diabetes
Sep  2, 2016FDA Extends Regulatory Review Period for IDegLira by Three Months
May 24, 2016IDegLira Receives Positive 16-0 Vote in Favour of Approval from FDA Advisory Committee

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