Novo Nordisk files NDA at FDA for Xultophy, combination of Tresiba (insulin degludec) and Victoza (liraglutide) to treat type 2 diabetes

Novo Nordisk has announced that a New Drug Application for Xultophy, the once-daily single-injection combination of Tresiba (insulin degludec) and Victoza (liraglutide) to treat type 2 diabetes, has been submitted to the FDA. Xultophy was approved in the EU in 2014.

Comment: The combination therapy makes sense for several reasons:

1. The two therapies act in complementary ways to lower blood glucose, meaning that the combination could be more effective than either therapy alone;
2. The weight loss provided by GLP-1 agonists can help reduce (or overcome) the weight gain associated with long-acting insulin therapy;
3. GLP-1 can be easier to take than short-acting insulin due to its glycemic-dependent nature (meaning it causes less hypoglycemia) and can delay the need for short-acting insulin.