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Combo Diabetes Treatment Soliqua Wins FDA Nod
The FDA has approved once-daily Soliqua 100/33 (Sanofi), a combination of Lantus (insulin glargine 100 U/mL) and the glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide (33 mcg/mL), for the treatment of adults with type-2 diabetes (T2D) inadequately controlled with basal insulin (less than 60 units daily) or lixisenatide alone.
In an insulin-intensification study, the American Diabetes Association target of a hemoglobin A1c level below 7% at 30 weeks was achieved by 55% of patients treated with Soliqua 100/33 compared with 30% of those treated with insulin glargine (Lantus) alone. The two treatment groups showed similar rates of hypoglycemia (less than or equal to 70 mg/dL). The most frequently reported adverse events included hypoglycemia as well as nausea (10%), nasopharyngitis (7%), diarrhea (7%), and upper respiratory tract infection (5%).
Soliqua 100/33 will be delivered in a single prefilled pen for once-daily dosing covering 15 to 60 units of insulin glargine 100 U/mL and five to 20 mcg of lixisenatide. The product will be available in U.S. retail pharmacies in January 2017.
Soliqua 100/33 has not been studied in people with a history of pancreatitis. It is not recommended for people who also take lixisenatide or other GLP-1 receptor agonists, nor is it for use in people with type-1 diabetes or diabetic ketoacidosis, or in those who have gastroparesis. Soliqua 100/33 has not been studied together with short-acting insulin. It is not known whether the product is safe and effective in children less than 18 years of age.
Sources: Sanofi; November 21, 2016; and Soliqua Prescribing Information; November 2016.