Sanofi gets FDA Approval of Once-Daily Basal Insulin Toujeo

Thursday, Feb 26, 2015

Sanofi announced that the U.S. Food and Drug Administration or (FDA)approved Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the U.S. at the beginning of the second-quarter of 2015.

The approval of Toujeo was based on FDA review of results from the EDITION clinical trial program, which was comprised of a series of international Phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults from broad and diverse diabetes populations (type 1 and type 2).

In the clinical trial program leading to approval, once-daily Toujeo was compared to that of once-daily Lantus (insulin glargine [rDNA origin] injection, 100 U/mL) in open-label, randomized, active-control, parallel, treat-to-target studies of up to 26 weeks of duration with 6 months safety extension.

The company noted that Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen which contains 450 units of Toujeo and requires one third of the injection volume to deliver the same number of insulin units as compared to the Lantus SoloSTAR.

The maximum single injection dose of 80 IU meets the needs of the vast majority of patients on basal insulin in the U.S., who require 80 IU or less per day.

Toujeo is currently pending marketing authorization with the European Medicines Agency (EMA) and other health authorities around the world.

Prescription Toujeo is a long-acting insulin used to treat adults with type 2 and type 1 diabetes for the control of high blood sugar. It should be taken once a day at the same time each day to lower blood glucose.

The company warned that do not use Toujeo to treat diabetic ketoacidosis.

It also warned that do not take Toujeo during episodes of low blood sugar or if you are allergic to insulin or any of the inactive ingredients in Toujeo. Toujeo is not approved for use in people under the age of 18.

The most common side effect of any insulin, including Toujeo, is low blood sugar (hypoglycemia), which may be serious and can be life-threatening.


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