Novo Nordisk announced that the Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted in favor (16-0) for the safety and efficacy of IDegLira in treating of adults with type 2 diabetes. IDegLira is a once-daily, single injection fixed combination product consisting of insulin degludec (Tresiba), a once-daily basal insulin analogue, and liraglutide (Victoza), a once-daily GLP-1 analogue.
The EMDACs decision was based on data from clinical trials of IDegLira that involved more than 3,000 adults with type 2 diabetes. In the IDegLira clinical development program, treatment scenarios studied included add-on to metformin (±pioglitazone and/or sulfonylurea), add-on to metformin (±pioglitazone and/or sulfonylurea) and GLP-1 (IDegLira replacing the GLP-1 agonist), and add-on to metformin and basal insulin (IDegLira replacing basal insulin) in patients needing additional glycemic control. All Phase 3 trials met their pre-specified primary endpoint, in fact, all trials showed superiority of IDegLira to comparator, even when non-inferiority was pre-specified.
IDegLira is a multi-ingredient product that combines an insulin with a GLP-1 agonist in a single container closure system. The introduction of a non-insulin component to what has traditionally been only insulin-based combination products presents a challenge with respect to the product’s labeling in order to ensure that the pen injector is likely to be used appropriately. To address concerns related to product labeling, the company was asked to conduct a labeling comprehension study with potential prescribing physicians. The study will also assess whether prescribers will be aware that there are two components to consider when starting therapy, making dose conversions, and changing therapy.
The NDA for IDegLira was submitted to the FDA in September 2015. The FDA is not bound by the Advisory Committee’s recommendation, but takes their advice into consideration when reviewing new drug applications.
“We look forward to working with the FDA to advance the IDegLira NDA towards approval,” said chief medical officer for Novo Nordisk, Todd Hobbs, MD. IDegLira was approved in Europe in September 2014 and is marketed there under the brand name Xultophy.
For more information visit Novonordisk-us.com.