Despite the unanimous backing of a Food and Drug Administration (FDA) advisory committee back in May, Novo Nordisk has announced there is to be a 3-month delay on a decision regarding US approval of its new injectable product, IDegLira, which combines fixed doses of its long-acting basal insulin degludec (Tresiba) with the glucagonlike-peptide 1 (GLP-1) receptor agonist liraglutide (Victoza, Novo Nordisk).
The FDA panel voted 16 to 0 in May that the product should be approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It's not clear why the product has been delayed — Novo Nordisk put out a brief statement saying that the FDA has extended the regulatory review period for IDegLira "in order to complete its review of the [new drug application] NDA."
A decision on IDegLira is now expected by December 2016, the company says.
The product is already available in Europe, where it is known as Xultophy and where just last week it was approved for the expanded indication of use in adults with type 2 diabetes who also have renal impairment, based on the results of the LIRA-RENAL trial.
LixiLan Will Probably Beat IDegLira to US Market Now
A similar delay was announced at the end of August for a competitor product from Sanofi called LixiLan, but the latter now looks set to beat IDegLira to the US market if it is approved.
That delay was because the US agency has requested more details about the pen delivery device for LixiLan, something that was a cause for concern among the FDA advisory panel members at the meeting, also in May, where LixiLan was recommended for approval.
Novo's Insulin/GLP-1 Agonist Combo IDegLira Delayed in US. Medscape. Sept 6, 2016.