FDA gives green light to Sanofi's once-daily Soliqua 100/33

The type 2 diabetes treatment for adults will be delivered using SoloStar technology.

Soliqua 100/33 is the combination of Lantus (insulin glargine 100 Units/mL) and lixisenatide, a GLP-1 receptor agonist, in a once-daily injection, studied in a Phase III program of more than 1,900 patients. In an insulin intensification study, Soliqua 100/33 showed better HbA1c (average blood sugar over time) lowering versus Lantus with a majority of the 736 patients (55% vs. 30%) achieving the American Diabetes Association target of less than 7% at 30 weeks. Patients treated with Soliqua 100/33 experienced similar rates of documented (less than or equal to 70 mg/dL) hypoglycemia compared to Lantus-treated patients.

Soliqua 100/33 will be delivered in a single pre-filled pen for once-daily dosing covering 15 to 60 Units of insulin glargine 100 Units/mL and 5 to 20 mcg of lixisenatide using SoloStar technology, the most frequently used disposable insulin injection pen platform in the world. Soliqua 100/33 will be available in US retail pharmacies in January 2017.

"Sanofi continues to be a pioneer in developing diabetes therapies and in bringing forward new treatment options for the approximately 50% of patients whose blood sugar levels remain uncontrolled on daily basal insulin. 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," said Elias Zerhouni, President, Global R&D, Sanofi.

The combination was submitted for regulatory review in a total of 10 markets, including the EU, where the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for the marketing authorization of the product on 11 November 2016. It has not yet been approved for use by any health authority outside the US.