The Food and Drug Administration (FDA) has approved an expanded indication for Soliqua 100/33 (insulin glargine and lixisenatide injection; Sanofi) to include use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) who are uncontrolled on oral antidiabetic agents, in addition to those inadequately controlled on basal insulin or lixisenatide.

Soliqua 100/33 is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. The approval was based on data from the LixiLan-O trial which included patients with T2DM uncontrolled with metformin and/or a second oral antidiabetic agent.

Results showed that at week 30, Soliqua 100/33 provided statistically significant improvement in HbA1c (P<.0001) compared with insulin glargine 100 units/mL and lixisenatide (-1.6%, -1.3%, and -0.9%). In addition, a greater proportion of patients treated with Soliqua 100/33 reached HbA1c <7% at week 30 compared with insulin glargine or lixisenatide (74% vs 59% and 33%, respectively).

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“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,” said Michelle Carnahan, North America Head of Primary Care, Sanofi.

Soliqua 100/33 is available as a single prefilled 3mL SoloStar pen in 5-count packages. The pen delivers doses ranging from 15–60 units in a single injection.

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