FDA Extends Review Period for IDegLira Diabetes Treatment

The FDA has extended the regulatory review period for Novo Nordisk’s IDegLira, a potential once-daily fixed combination of insulin degludec (Tresiba) and liraglutide (Victoza) for adults with type 2 diabetes.

Novo Nordisk originally submitted the New Drug Application for IDegLira in September 2015, and the product received a unanimous 16-0 vote in favor of approval from an FDA advisory committee in May 2016. However, the FDA just informed the manufacturer that a 3-month extension is required to complete its review of the drug.

With this extension, the FDA’s anticipated action date is now in December 2016.

Back in September 2014, the drug was granted marketing authorization by the European Commission under the brand name of Xultophy. In Europe, the product is indicated for the treatment of adults with type 2 diabetes to improve glycemic control in combination with oral glucose-lowering medicinal products when they alone or combined with basal insulin do not provide enough glycemic control.

“We believe that Xultophy represents a new paradigm with the potential to transform how type 2 diabetes is treated,” stated Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, at the time of the drug’s approval in Europe.

Xultophy has been shown to improve glycemic control in insulin-naïve patients with type 2 diabetes, as well as those uncontrolled on basal insulin. In the latter group, Xultophy has demonstrated significant reduction in HbA1C.