Expanded Indication for Soliqua 100/33
February 27, 2019 – The U.S. FDA has approved an expanded indication for Soliqua® 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL, manufactured by Sanofi. The product is now indicated for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes who are unable to achieve control on oral antidiabetic medications.
First approved in 2016, Soliqua 100/33 was previously only indicated for use by adult patients who were uncontrolled on long-acting insulin or lixisenatide. The expanded indication is based on clinical studies in which Soliqua 100/33 produced significantly greater reductions in blood sugar levels compared to insulin glargine and lixisenatide in patients who had not achieved adequate control with metformin and/or a second oral antidiabetic therapy. A greater percentage of patients reached their target blood sugar levels with Soliqua 100/33 (74%) compared to insulin glargine (59%) and lixisenatide (33%).
Recommended dosing requires once-daily subcutaneous injection during the hour before the first meal of the day. Dosage strength depends on individual patient factors, but should not exceed 60 units per day.