FDA Green Lights Soliqua 100/33 for Type 2 Diabetes

The FDA has approved Sanofi’s once-daily Soliqua 100/33 (insulin glargine and lixisenatide injection) for the treatment of adults with type 2 diabetes. It is indicated to improve blood sugar control in adults who are not controlled with basal insulin (less than 60 Units daily) or lixisenatide.

In a phase 3 clinical trial of more than 1900 patients, Soliqua 100/33 showed better HbA1c lowering compared to Lantus, with most of the patients achieving the American Diabetes Association target of less than 7% at 30 weks (55% in the Soliqua group compared with 30% in the Lantus group). Patients treated with the drug experienced similar rates of documented (less than or equal to 70 mg/dL) hypoglycemia compared to patients treated with Lantus. Commonly reported adverse events include hypoglycemia, nausea, nasopharyngitis, diarrhea, and upper respiratory tract infection.

Soliqua 100/33 will be delivered in a single pre-filled pen for once-daily dosing in 15 to 60 units of insulin glargine 100 units/mL and 5 to 20 mcg of lixisenatide. It will be available in US retail pharmacies in January 2017.

The approval was announced on the same day as Novo Nordisk’s combination product, Xultophy was approved.