Toujeo (insulin glargine [rDNA origin]) is an insulin injection approved for the treatment of type 1 and type 2 diabetes to improve glycaemic control in adult patients. The drug was discovered and developed by Sanofi.
Toujeo was approved by US Food and Drug Administration (FDA) as a once-daily long-acting basal insulin to improve the glycaemic index in patients suffering from type 1 and type 2 diabetes in February 2015.
A new drug application (NDA) of the drug was accepted for review by the FDA in July 2014 following acceptance of the marketing authorisation application by the European Medicines Agency (EMA) for EU countries in May 2014.
The marketing authorisation request of Toujeo is under review with EMA and other health authorities worldwide. The drug is expected to be available in the US in the second quarter of 2015, subject to approval.
Glycaemic control in type 1 and type 2 diabetics
In both cases, glycaemic control plays a crucial role as it involves maintaining normal blood sugar levels in patients with diabetes mellitus. Good glycaemic control is an important part of diabetes care as both hyperglycaemia (elevated blood sugar levels) and hypoglycaemia (low blood sugar) may lead to chronic complications of diabetes.
Toujeo’s mechanism of action
Toujeo contains an active ingredient called insulin glargine whose primary activity is to regulate glucose metabolism by controlling high blood sugar levels in patients with type 1 and type 2 diabetes. Insulin glargine reduces blood glucose by stimulating peripheral glucose uptake and inhibiting hepatic glucose production.
Tanzeum (albiglutide), developed by GlaxoSmithKline, is a GLP-1 receptor agonist indicated for treatment of type 2 diabetes.
Toujeo will be available in a disposable prefilled pen called Toujeo SoloSTAR, which contains 450 units of Toujeo and requires one third of the injection volume to deliver the same number of insulin units.
Clinical trials on Toujeo
The FDA-approval for Toujeo was based on results from a clinical trial programme known as Edition, which is comprised of a series of three Phase III clinical trials that evaluated Toujeo’s safety and efficacy.
The studies were conducted on more than 3,500 adult type 1 and type 2 diabetics.
The open-label, randomised, active-control, parallel, treat-to-target studies compared Toujeo with once-daily Lantus (insulin glargine [rDNA origin] injection, 100 U/mL). The trial was conducted for 26 weeks with six months safety extension.
Results from the Phase III study demonstrated that significantly fewer people with type 2 diabetes, new to insulin therapy, experienced low blood sugar events during the night over the study period when treated with Toujeo compared with Lantus during the first eight-week titration phase.
The pooled analysis consistently demonstrated fewer low blood sugar events in type 2 diabetics, new to insulin therapy, at any time of day, including night-time events, compared with Lantus. All studies showed similar blood sugar control with Toujeo compared to Lantus and met the primary end points.
The most common adverse reactions reported were nasopharyngitis and upper respiratory tract infection.
Sanofi specialises in discovering innovative and personalised solutions to help people manage diabetes. It takes a unique approach of engaging with people suffering with diabetes, derives insights from it and forms a partnership to offer diagnostics, therapies, services and devices. The company markets injectable, inhaled and oral medications for type 1 or type 2 diabetes.