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Sanofi announced that the U.S. Food and Drug Administration (FDA) approved once-daily Soliqua™ 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide.
Soliqua 100/33 is the combination of Lantus® (insulin glargine 100 Units/mL) and lixisenatide, a GLP-1 receptor agonist, in a once-daily injection, studied in a Phase 3 program of more than 1,900 patients. In an insulin intensification study, Soliqua 100/33 showed better HbA1c (average blood sugar over time) lowering versus Lantus with a majority of the 736 patients (55% vs. 30%) achieving the American Diabetes Association target of less than 7% at 30 weeks. Patients treated with Soliqua 100/33 experienced similar rates of documented (less than or equal to 70 mg/dL) hypoglycemia compared to Lantus-treated patients. 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 pre-filled pen for once-daily dosing covering 15 to 60 Units of insulin glargine 100 Units/mL and 5 to 20 mcg of lixisenatide using SoloStar technology, the most frequently used disposable insulin injection pen platform in the world. Soliqua 100/33 will be available in U.S. retail pharmacies in January 2017.
“Sanofi continues to be a pioneer in developing diabetes therapies and in bringing forward new treatment options for the approximately 50 percent of patients whose blood sugar levels remain uncontrolled on daily basal insulin. Soliqua 100/33 is an alternate new approach that can help adults living with type 2 diabetes uncontrolled on basal insulin or lixisenatide to reach their treatment goal,” said Elias Zerhouni, M.D., President, Global R&D, Sanofi.
The combination was submitted for regulatory review in a total of 10 markets, including the EU, where the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for the marketing authorization of the product on November 11, 2016. It has not yet been approved for use by any health authority outside the U.S.
