FDA Approves Xultophy for Adults with Type 2 Diabetes

The FDA has approved Xultophy 100/3.6 (insulin degludec and liraglutide injection) for the reduction of A1c in adults with type 2 diabetes inadequately controlled by basal insulin or liraglutide alone.

The injection is a once-daily combination of insulin degludec and liraglutide, and was approved based on the results of the Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes clinical development program. In 3 trials incolving 1393 adults with type 2 diabetes, patients taking Xultophy achieved reductions in A1c.

The most common adverse events reported during the development program included nasopharyngitis, headache, nausea, diarrhea, increased lipase, and upper respiratory tract infection.

—Michael Potts

Reference:

Novo Nordisk. Novo Nordisk receives FDA approval for Xultophy® 100/3.6 (insulin degludec and liraglutide injection) [press release]. November 21, 2016. Accessed November 23, 2016. http://press.novonordisk-us.com/2016-11-21-Novo-Nordisk-Receives-FDA-Approval-for-Xultophy-100-3-6-insulin-degludec-and-liraglutide-injection.