Sanofi Insulin Glargine and Lixsenatide Injection Label Expanded by FDA

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The 100 Units/mL/ 300 mcg/mL-dosed therapy was previously approved as an add-on therapy to diet and exercise in adults with T2D.

The US Food and Drug Administration (FDA) has approved the expanded use of insulin glargine and lixsenatide injection 100/33 (Soliqua) as a therapy for adult patients with type 2 diabetes (T2D) uncontrolled by oral antidiabetic medicines.

The 100 Units/mL/ 300 mcg/mL-dosed therapy was previously approved as an add-on therapy to diet and exercise in adults with T2D. The FDA expanded its indication based on the results of the LixiLan-O clinical trial, which assessed the drug in adults with T2D uncontrolled with metformin and/or another oral antidiabetic therapy.

Patients treated with Soliqua 100/33 reported significantly greater reductions in blood sugar levels (-1.6%) versus patients controlled with insulin glargine and lixisenatide (-1.3%; -0.9%, respectively) (P < .0001). Significantly more patients treated with Soliqua 100/33 reached their target blood sugar levels (74%) than those on insulin glargine (59%) or lixisenatide (33%).

Low blood sugar events were similar between Soliqua 100/33 (25.6%) and insulin glargine (23.6%) patients, but notably lower in patients on lixisenatide (6.4%). Common adverse events—which, investigators noted were more likely to be observed at the trial’s beginning—in Soliqua 100/33-treated patients included nausea (9.6%) and vomiting (3.2%).

The therapy is not intended for use in patients with type 1 diabetes, and is not cleared as a safe nor efficacious drug in children. In its announcement of the expanded indication, Sanofi stated it will continue to offer the therapy as part of a savings program that can limit out-of-pocket expenses to as low as $0 for commercially-insured patients—regardless of insurance plan or income level.

Adults with T2D mainly control their condition through diet and exercise alone, Michelle Carnahan, North America Head of Primary Care for Sanofi, said in a statement. Additional blood sugar level-lowering therapies could prove beneficial for them.

“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,” Carnahan said.