The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted 16–0 in favor of approving IDegLira (Novo Nordisk) for the treatment of adults with type-2 diabetes (T2D). IDegLira is a once-daily, single-injection fixed combination of insulin degludec (Tresiba), a once-daily basal insulin analogue, and liraglutide (Victoza), a once-daily glucagon-like peptide-1 (GLP-1) analogue.
FDA advisory committees are panels of independent experts who advise the FDA on specific questions raised by the agency as it considers regulatory decisions. The FDA is not bound by its committees’ recommendations, but it takes their advice into consideration when reviewing new drug applications (NDAs).
Based on the data included in the NDA for IDegLira, the FDA asked the panel members to discuss whether Novo Nordisk had provided adequate evidence to establish the efficacy and safety profile of IDegLira for the treatment of adults with T2D.
The recommendation for approval was based on results from clinical studies of IDegLira, including the phase 3 DUAL clinical trial program, which involved more than 3,000 adults with T2D. In addition to the DUAL program, both insulin degludec and liraglutide have been studied in separate clinical trial programs, and the products are commercially available around the world.
The NDA for IDegLira was submitted to the FDA in September 2015.
In data from the phase 3b DUAL V trial, reported in June 2015, DegLira demonstrated a statistically significant reduction in HbA1c (average blood glucose over the previous three months), change in body weight, and a lower rate of hypoglycemia compared with patients treated with insulin glargine. Both therapies were added to metformin.
At 26 weeks, patients receiving IDegLira achieved a statistically significant mean reduction in HbA1c of 1.8% from baseline compared with a 1.1% reduction in patients who further increased their dose of insulin glargine (P ˂ 0.001). In the IDegLira group, 72% of patients achieved an HbA1c of less than 7% at the end of the trial compared with 47% of patients in the insulin glargine group (P ˂ 0.001). Further, 39% of patients treated with IDegLira achieved an HbA1c of less than 7% without hypoglycemia and weight gain compared with 12% of those treated with insulin glargine (P ˂ 0.001).