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Toujeo Launches in the US – The Next Generation Lantus

Update (4/3/15): New basal insulin Toujeo (insulin glargine U300) has now launched in the US, around a month after its FDA approval. In what we think is fantastic news, Toujeo will be priced around the same as Lantus (insulin glargine U100) per unit. You can find a detailed injection guide for using the updated SoloStar pen for Toujeo on the website. We’re most excited for this product in terms of “next generation” combo products (more on that below). Based on clinical trial data, for some Toujeo may lead to nighttime hypoglycemia and/or weight loss benefits, although this is not technically on the label.

The product also has an impressive COACH patient support program (available free to anyone with a Toujeo prescription) that provides live one-on-one phone calls with a COACH guide, online resources, tips via text message, and even diabetes educator-led in-person sessions. We can’t wait to see how this works in real life; if you’re using Toujeo’s COACH program, please let us know your impressions by e-mailing us. A savings card also allows patients with commercial insurance (but not Medicare/Medicaid/VA patients) to pay no more than $15 per prescription for the next year. Although many criticize the high price of insulin in the US, it’s good to see the availability of saving programs for Toujeo for people with insurance. 

Original Article (3/5/15):

Twitter summary: .@US_FDA approves Toujeo, more concentrated version of basal insulin Lantus – our story on data, delivery, & a promising future

In late February, Sanofi announced FDA approval of its once-daily, long-acting basal insulin Toujeo. Toujeo is the same type of basal insulin (glargine) as Sanofi’s blockbuster Lantus, but a stronger version. In Toujeo, each milliliter of liquid carries 300 units of insulin (“U300”), whereas Lantus only carries 100 units of insulin per milliliter (“U100”). Sanofi hopes to bring Toujeo to the market in the next month – a very quick turnaround! It has also been tentatively approved in Europe, with a final decision expected in the coming months. Pricing and insurance information are not available at this time.

Toujeo will be sold in a new SoloStar pen that will carry 450 units, 50% more than the 300-unit Lantus pen – a major improvement for the many people who require larger doses of insulin. In Sanofi’s New Medicines Seminar in November, we learned that Toujeo will come with a substantial patient support program, using multiple forms of contact (online, phone, in person) to help patients transition onto the new insulin.

Toujeo’s approval was based on the results of the EDITION clinical trials, which evaluated its efficacy and safety compared to Lantus in over 3,500 adults with type 1 and type 2 diabetes. In short, Toujeo was found to be just as safe and effective as Lantus. In the trials, Toujeo was slightly more effective at lowering A1c than Lantus, had no significant difference in weight gain, and had mixed results for potential hypoglycemia benefits (some trials showed a benefit, others did not). We wonder if the real-world experience with Toujeo will show larger benefits on hypoglycemia. Full information on the drug’s dosing and side effects can be found here.

Toujeo’s approval clears the path for a combination with the GLP-1 agonist lixisenatide. Novo Nordisk’s Xultophy (a combination of Victoza and Tresiba) is the only currently approved GLP-1 agonist/ basal insulin combination drug, having received approval in Europe last September. While Toujeo could be a valuable option for many by itself, we most look forward to its combination with lixisenatide. –ER/AJW