Insulin glargine/lixisenatide, sold under the brand name Soliqua 100/33 among others,  is a fixed-dose combination medication that combines insulin glargine and lixisenatide and is used to treat diabetes. The most common side effects include hypoglycemia (low blood glucose), diarrhea, vomiting and nausea (feeling sick).Insulin glargine/lixisenatide was approved for medical use in the United States in November 2016, and in the European Union in January 2017. Medical uses
Insulin glargine/lixisenatide is approved as a prescription for adults with type 2 diabetes mellitus poorly controlled by lixisenatide or basal insulin alone. According to the American Diabetes Association, combination treatment of a GLP-1 receptor agonist with basal insulin should occur after HbA1C levels remain above target (7% for most type 2 people with diabetes) following use of basal insulin.The use of insulin glargine/lixisenatide and lixisenatide-containing products is not recommended for use while pregnant. There is insufficient data in humans to form a pregnancy risk category for lixisenatide. Animal pregnancy studies have shown potential risks to the prenate, but it is unclear if these risks are related to the drug. It is unknown if insulin glargine and lixisenatide are present in human milk or the effects these drugs would have on breastfed infants. Potential adverse effects to the mother and child as well as management of diabetes and glucose control should be considered prior to use of Soliqua during breastfeeding. Adverse effects
Prior to the approval of insulin glargine/lixisenatide, two studies were conducted to evaluate the safety of the formulation.
In November 2016, the FDA approved Sanofis Soliqua formulation (insulin glargine 100 units/mL and lixisenatide 33 mcg/mL). Soliqua became available in American pharmacies in January 2017. Society and culture
Cost
Following the US approval of Soliqua, Sanofi made a US$25 million milestone payment to Zealand. Zealand may receive additional payments up to US$110 million along with receiving royalties on global sales. Royalties paid to Zealand for Soliqua are based on a fixed low double-digit percentage of net sales.In January 2017, Sanofi announced that the wholesale acquisition cost (WAC) of a 3 ml pen of Soliqua is US$127. At the average dose used in clinical trials, this amounts to US$19.90 per day.According to Sanofis Half-Year Financial Report, the net sales of Soliqua reached €9 million in the first six months of availability in the United States. Brands
Insulin glargine/lixisenatide was called HOE901/AVE0010 during development and as of October 2017, had been marketed under the brand names iGlarLixi, Lantus/Lyxumia, LixiLan, and Soliqua. References
External links
"Insulin glargine mixture with lixisenatide". Drug Information Portal. U.S. National Library of Medicine.