Posted by Michael Wonder on 28 Feb 2019
FDA expands indication for Soliqua 100/33
27 February 2019 - Soliqua 100/33 now approved as an add-on to diet and exercise for adults with type 2 diabetes.
The U.S. FDA) has approved the expanded use of Soliqua 100/33 (insulin glargine and lixisenatide injection) 100 units/mL and 33 mcg/mL. Previously approved for use as an add-on to diet and exercise in adults with type 2 diabetes who are uncontrolled on long-acting insulin or lixisenatide, Soliqua 100/33 can now also be prescribed for patients uncontrolled on oral anti-diabetic medicines.
The FDA approval was based on data from the LixiLan-O clinical trial which showed, in adults with type 2 diabetes uncontrolled with metformin and/or a second oral anti-diabetic therapy, that treatment with Soliqua 100/33 led to significantly greater reductions in blood sugar levels compared with insulin glargine and lixisenatide (-1.6%, -1.3%, -0.9%, respectively; p<0.0001).
