Soliqua Approval History

• FDA approved: Yes (First approved November 21st, 2016)
• Brand name: Soliqua
• Generic name: insulin glargine and lixisenatide
• Dosage form: Injection
• Previous name: iGlarLixi
• Company: Sanofi-Aventis U.S. LLC
• Treatment for: Diabetes, Type 2

Soliqua 100/33 (insulin glargine and lixisenatide) is fixed-ratio combination of the long-acting human insulin analog insulin glargine (Lantus) and the glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide (Adlyxin), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

FDA approval of Soliqua 100/33 was based on results of the LixiLan-O and LixiLan-L Phase 3 studies of more than 1,900 patients with type 2 diabetes. LixiLan-O investigated the insulin glargine/lixisenatide fixed-ratio combination compared with insulin glargine and lixisenatide alone in 1170 patients, and Lixilan-L investigated the combination compared with insulin glargine in 736 patients. Results from both studies demonstrated significantly greater reductions in HbA1c in patients treated with the insulin glargine/lixisenatide fixed-ratio combination.

Soliqua 100/33 is administered subcutaneously in the thigh, upper arm, or abdomen via a prefilled, pen injector once a day within the hour prior to the first meal of the day. Common side effects include hypoglycemia, allergic reactions, nausea, stuffy or runny nose, diarrhea, upper respiratory tract infection, and headache.

Development History and FDA Approval Process for Soliqua

Date	Article
Nov 21, 2016	Sanofi Receives FDA Approval of Soliqua 100/33 (insulin glargine and lixisenatide) for the Treatment of Adults with Type 2 Diabetes
Aug 20, 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
May 25, 2016	FDA Advisory Committee Recommends Approval of Sanofi Treatment for Adults With Type 2 Diabetes
Feb 22, 2016	FDA Accepts Sanofi NDA for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide
Dec 23, 2015	Sanofi Submits NDA for Once-Daily Fixed-Ratio Combination of Insulin Glargine and Lixisenatide
Jul 29, 2015	Sanofi Announces That First LixiLan Phase III Study Met Primary Endpoint

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