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# FDA Extends Review of Novo Nordisk Diabetes Drug Combo
- URL: https://www.fdaweb.com/fda-extends-review-of-novo-nordisk-diabetes-drug-combo/
- Published: 2016-09-06T12:00:00.000Z
- Updated: 2026-09-14T21:29:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136712

FDA has extended by three months the review of a Novo Nordisk NDA for IDegLira, a fixed-dose combination of Victoza (liraglutide), a glucagon-like peptide-1 receptor agonist, and Tresiba (insulin degludec), a long-acting insulin analog. The company submitted the NDA 9/2015, and with the review extension the action date is expected in December.

In May, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 to support the product’s safety and efficacy for the proposed indication of adjunct to diet and exercise to improve glycemic control in treating adults with Type 2 diabetes. Committee members generally indicated that the data supporting the drug’s efficacy were compelling and that no unexpected safety issues were seen in the clinical trials. One committee member suggested that FDA consider requiring a post-approval study evaluating Xultophy’s efficacy beyond 26 weeks. Also suggested was a post-approval study to assess weight reduction with treatment for 12 months or longer, and a study to help define patients in whom treatment is ineffective to better guide appropriate use of the product.