FDA Expands Indication for Soliqua® 100/33

The U.S. Food and Drug Administration (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 antidiabetic medicines.

"Many people living with type 2 diabetes are uncontrolled on diet and exercise alone and could require additional interventions to help lower their blood sugar levels," said Michelle Carnahan, North America Head of Primary Care, Sanofi. "This FDA decision marks the first combination insulin and GLP-1 injectable medicine approved for adults living with type 2 diabetes who are uncontrolled with diet and exercise, potentially providing them access to an option that can help them achieve their treatment goals."

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 antidiabetic 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). In addition, significantly more patients reached their target blood sugar levels with Soliqua 100/33 (74%) compared with insulin glargine (59%) or lixisenatide (33%). Low blood sugar events were similar between Soliqua 100/33 (25.6%) and insulin glargine (23.6%), but were lower with lixisenatide (6.4%). The most common adverse events generally at the beginning of treatment in the Soliqua 100/33 arm were nausea (9.6%) and vomiting (3.2%).

Soliqua 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, which may improve blood sugar (glucose) control in adults with type 2 diabetes when used with diet and exercise.

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