Branded products in diabetes care commercialized by Sanofi under an exclusive worldwide license.

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Zealand's first invented medicine, lixisenatide, a once-daily prandial GLP-1 receptor agonist for the treatment of type 2 diabetes, is licensed to Sanofi.
Lixisenatide is available as Adlyxin® in the U.S. and is approved as Lyxumia® in more than 61 countries worldwide and marketed in over 45 by Sanofi. Commercial launches include most EU countries, Japan, Brazil, Mexico, India and the U.S. as of January 2017. Adlyxin®/Lyxumia® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Clinical trials

GetGoal Duo-2

In an international Phase 2 trial, GetGoal, which included 11 clinical studies involving more than 5,000 patients with Type 2 diabetes, lixisenatide has shown to have a similar effect on glucose reduction with advantages on body weight compared to rapid-acting insulin, when added to basal insulin for treatment intensification in patients with Type 2 diabetes.

The results establish the product as the first once-daily prandial GLP-1 receptor agonist, characterized by a pronounced lowering effect on post-prandial glucose (PPG) contributing to HbA1c reduction, a beneficial effect on body weight, and a limited risk of hypoglycemia. The PPG-lowering effect of lixisenatide complements the predominantly fasting plasma glucose (FPG)-lowering effect of basal insulin, making Lyxumia® particularly relevant as an add-on therapy to basal insulin, including Lantus®, to better control blood sugar.

Intense – “real-world” observational study of lyxumia® initiated in Europe

Sanofi has initiated the INTENSE (Intensifying iNsulin Therapy in type 2 diabetes: lixisENatide or Standard of carE) trial, a new patient-centric non-interventional study of Lyxumia® compared to other forms of injectable insulin intensification therapies, including short acting insulin. INTENSE, which is being initiated in several European countries, has a prospective recruitment of 2,400 adults with Type 2 diabetes, and will assess the safety and efficacy of adding injectable therapies to basal insulin, as well as the factors predicting the effectiveness of this intensification of treatment in a real-world standard of care setting.

INTENSE will follow patients to also examine the ways real-life circumstances can impact patients’ perceptions, their ability to manage diabetes and their adherence to treatment. The first participant in this large-scale, post-approval observational study was enrolled at the end of July 2014 at Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas, Gran Canaria, Spain.

Elixa – study establishes cardiovascular safety profile of lixisenatide

In June 2015, at the American Diabetes Association (ADA) 75th Scientific Sessions in Boston, Sanofi presented full results of ELIXA, a Phase 3b cardiovascular safety outcomes trial of lixisenatide (Lyxumia®/Adlyxin™) compared to placebo in a cardiovascular high-risk population of adults with Type 2 diabetes. The results demonstrated lixisenatide to be safe versus placebo on all cardiovascular safety parameters and the outcome establishes lixisenatide as the first glucacon-like peptide-1 receptor agonist (GLP-1 RA) with proven cardiovascular safety.
The results from ELIXA showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety, and demonstrate that there is no additional cardiovascular risk, in a high-risk patient population, associated with treatment with lixisenatide. Additional safety findings included no signal for increased risk of heart failure, pancreatitis, pancreatic cancer or severe symptomatic hypoglycemia.

ELIXA is the first event-driven cardiovascular outcomes trial to have provided data for a medicine from the GLP-1 receptor agonist class. The trial was a randomized, double-blind, and parallel group design comparing lixisenatide to placebo in a population of adults with Type 2 diabetes and high cardiovascular risk (patients who have recently experienced a spontaneous acute coronary syndrome event). More than 6,000 patients participated and were treated in the trial. The composite primary endpoint, which was evaluated for non-inferiority and superiority, comprised cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for unstable angina.

The global ELIXA study started in June 2010 and was completed in March 2015.