On November 21, the U.S. Food and Drug Administration (FDA) approved the injectable combination medicines Soliqua 100/33 (insulin glargine and lixisenatide injection) and Xultophy 100/3.6 (insulin degludec and liraglutide injection) for Type 2 diabetes. Soliqua 100/33, manufactured by Sanofi, combines the glucagon-like peptide-1 (GLP-1) agonist Adlyxin with the basal insulin Lantus (insulin glargine 100 units/ml). Xultophy, manufactured by Novo Nordisk, combines the GLP-1 agonist Victoza (liraglutide) with the basal insulin Tresiba (insulin degludec injection).
GLP-1 agonists work by stimulating the insulin-producing beta cells of the pancreas to release insulin in response to high blood glucose levels. Because of their glucose-dependent mechanism of action, drugs of this class are associated with a low rate of hypoglycemia (low blood glucose). Basal, or background insulin, is typically taken once daily to cover the liver’s secretion of glucose into the bloodstream.
Soliqua 100/33 is approved for use in adults with Type 2 diabetes whose blood sugar is not adequately controlled with less than 60 units a day of basal insulin or with Adlyxin. The approval was based on studies in more than 1900 people showing that Soliqua 100/33 resulted in lower HbA1c levels (a measure of glucose control over the previous 2–3 months) compared to Lantus alone. Xultophy 100/3.6 is approved for use in adults with Type 2 diabetes whose blood sugar is not adequately controlled with less than 50 units a day of basal insulin or 1.8 milligrams or less of Victoza a day. The approval was based on a study in 1393 people with Type 2 diabetes who did not achieve blood sugar control with basal insulin or Victoza, showing significant reductions in HbA1c when they were switched to Xultophy 100/3.6.
Soliqua 100/33 is taken in a once-daily injection covering a dose of 15 to 60 units of Lantus and 5 to 20 micrograms of Adlyxin and will come in a single, prefilled pen that uses SoloStar technology. The medicine will be available in the United States beginning in January 2017. Xultophy is taken in a once-daily injection, with or without food, from a prefilled pen, with a starting dose of 16 units (16 units of Tresiba and 0.58 milligrams of liraglutide) and a maximum dose of 50 units (50 units of Tresiba and 1.8 milligrams of liraglutide). The medicine is expected to be available in the United States in the first half of 2017.
According to both manufacturers, the medications will be sold at discounted prices compared to the cost of the combined ingredients: Soliqua 100/33 is expected to cost roughly the same as a GLP-1 agonist, while Xultophy is anticipated to be offered at a 20% discount off the combined price of Tresiba and Victoza.
The most common side effects of Soliqua 100/33 include hypoglycemia, nausea, headache, stuffy or runny nose and sore throat, allergic reactions, diarrhea, and upper respiratory tract infection. Soliqua 100/33 may increase the risk of pancreatitis, or inflammation of the pancreas. Before taking Soliqua 100/33, you should speak to your doctor if you have had pancreatitis, gallbladder stones, or a history of alcoholism, as these can increase your risk of pancreatitis. The most common side effects of Xultophy 100/3.6 include stuffy or runny nose, sore throat, upper respiratory tract infection, increased blood levels of lipase (a type of enzyme that breaks down fats in food), nausea, diarrhea, and headache. Xultophy 100 /3.6 may increase the risk of thyroid tumors. People who have had medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) should not use Xultophy 100/3.6.
For more information on Soliqua 100/33 and Xultophy 100/3.6, see the press releases on the Sanofi and Novo Nordisk websites, respectively.
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