FDA Approval Alert: Sanofi Insulin Combination Approved for Diabetes

The US Food and Drug Administration has approved once-daily Soliqua™ 100/33 (100 Units/mL and 33 mcg/mL [Sanofi]) for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide.

-----

Related Content

Abdominal Fat and Risk of Cardiovascular Disease

Legislation to Revamp Medicare for Chronic Conditions Recently Drafted

-----

The approval was based on data from phase 3 studies of more than 1900 patients with type 2 diabetes. Those who were treated with Soliqua, a combination of 100 Unites/mL of insulin glargine and the glucagon-like peptide-1 (GLP1) receptor agonist lixisenatide, were more likely to achieve improved HbA1c (average blood sugar over time) lowering compared with those who received insulin glargine alone, with the majority of 736 patients in the insulin intensification study reaching the American Diabetes Association recommended glycemic target of less than 7% A1C at 30 weeks.

The most common adverse events associated with Soliqua treatment were nausea (10%), which is associated with early weeks of GLP-1 therapy, diarrhea (7%), nasopharyngitis (7%), and upper respiratory tract infection (5%).

"Sanofi continues to be a pioneer in developing diabetes therapies and in bringing forward new treatment options for the approximately 50 percent of patients whose blood sugar levels remain uncontrolled on daily basal insulin,” said Sanofi president of global R&D, Elias Zerhouni, MD. “Soliqua 100/33 is an alternate new approach that can help adults living with type 2 diabetes uncontrolled on basal insulin or lixisenatide to reach their treatment goal."

This new treatment comes at a critical point in the United States, where more than 27 million people have type 2 diabetes and many more may develop the condition as they progress to old age.--Sean McGuire