Posted from: Monday, April 08, 2019 - 04:28 PM - Present

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. 


Last Updated Friday, October 18, 2019 - 12:43 AM.