FDA Expands Indication for Soliqua 100/33 (insulin glargine and lixisenatide injection) to Include Type 2 Diabetes Patients Uncontrolled on Oral Antidiabetic Medicines
BRIDGEWATER, N.J., Feb. 27, 2019 /PRNewswire/ — 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%).
Sanofi will continue offering its savings program for Soliqua 100/33 which can limit out-of-pocket expenses sometimes to $0 for all commercially insured patients regardless of formulary status on an insurance plan or income level. For more information about this program, visit www.soliqua100-33.com.
About Soliqua 100/33
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.
- It has not been studied in people with a history of pancreatitis.
- It is not recommended for people who also take lixisenatide or other medicines called GLP-1 receptor agonists.
- It is not for use in people with type 1 diabetes, or people with diabetic ketoacidosis.
- It has not been studied in people who have a stomach problem that causes slow emptying (gastroparesis) and is not for people with slow emptying of the stomach.
- It has not been studied in people who also take a short-acting (prandial) insulin.
- It is not known if Soliqua 100/33 is safe and effective in children under 18 years of age.
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Posted: February 2019
- Sanofi Receives FDA Approval of Soliqua 100/33 (insulin glargine and lixisenatide) for the Treatment of Adults with Type 2 Diabetes – November 21, 2016
- Zealand Announces New Timelines for a U.S. FDA Decision on iGlarLixi, the Fixed-Ratio Combination of Lixisenatide (Adlyxin) and Lantus, for the Treatment of Type 2 Diabetes – August 20, 2016
- FDA Advisory Committee Recommends Approval of Sanofi Treatment for Adults With Type 2 Diabetes – May 25, 2016
- FDA Accepts Sanofi NDA for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide – February 22, 2016
- Sanofi Submits NDA for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide – December 23, 2015
Soliqua 100/33 (insulin glargine and lixisenatide) FDA Approval History
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