The US Food and Drug Administration (FDA) has approved once-daily SoliquaTM 100/33 (Sanofi) for use in adults with type 2 diabetes, according to a press release from the manufacturer.
The once-daily injection is a combination of Lantus® (insulin glargine 100 units/mL) and the glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide 33 mcg/mL (Adlyxin®, Sanofi). Treatment is delivered through a single, prefilled pen, which covers 15 to 60 units of insulin glargine and 5 mcg to 20 mcg of lixisenatide, and is intended to improve blood sugar control in adults whose diabetes is poorly controlled through basal insulin or lixisenatide alone.
In May 2016, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 12-2 in favor of recommending approval of insulin glargine/lixisenatide.
A phase 3 trial of 1900 patients found that those treated with Soliqua 100/33 had lower HbA1c over time vs insulin glargine alone, with 55% of patients vs 30% achieving the American Diabetes Association (ADA) target HbA1c level of less than 7% at 30 weeks, according to the release. Rates of hypoglycemia were comparable to those found in patients treated with insulin glargine alone.
“Soliqua 100/33 is an alternate approach that can help adults living with type 2 diabetes uncontrolled on basal insulin or lixisenatide to reach their treatment goal,” said Elias Zerhouni, MD, president of Global Research and Development at Sanofi, in a press release.
Soliqua 100/33 will be available in US pharmacies beginning January 2017. The drug is not approved for use in those younger than 18.
- Sanofi receives FDA approval of SoliquaTM 100/33, for the treatment of adults with type 2 diabetes [news release]. Paris, France: Sanofi; November 21, 2016. Accessed November 22, 2016.