November 21, 2016
USFDA today approved New Drug Applications once-daily Soliqua (Sanofi) 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL
Xultophy (Novo Nordisk) 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection) for the treatment of adults with type 2 diabetes inadequately controlled.
Insulin glargine + Lixisenatide ( Soliqua)
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 3 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.2 Soliqua 100/33 will be available in U.S. retail pharmacies in January 2017.
The most frequently reported adverse events included hypoglycemia, as well as nausea (10%), nasopharyngitis (7%), diarrhea (7%) and upper respiratory tract infection (5%).
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 November 11, 2016. It has not yet been approved for use by any health authority outside the U.S.
Insulin Degludec + Liraglutide (Xultophy)
New Drug Application for Xultophy® 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection). Xultophy® 100/3.6 is a once-daily, combination of Tresiba® (insulin degludec injection) and Victoza® (liraglutide) injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8 mg of liraglutide daily.1 Xultophy® 100/3.6 enters into a new class of diabetes treatments that combine a basal insulin and a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in a single, once-daily injection.
The approval of Xultophy® 100/3.6 is based on efficacy and safety data from the DUAL™ (Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes) clinical development program. In three DUAL™ trials involving 1,393 adults with type 2 diabetes, patients who were inadequately controlled on liraglutide or basal insulin therapy and switched to Xultophy® 100/3.6 achieved reductions in A1C.2,3 For adults uncontrolled on basal insulin, Xultophy® 100/3.6 demonstrated significant reductions in A1C from baseline of 1.67% and 1.94%.2,4The most common adverse events seen during the DUAL™ clinical development program included nasopharyngitis, headache, nausea, diarrhea, increased lipase, and upper respiratory tract infection.