Once-Daily Long-Acting Basal Insulin Toujeo

Bridgewater, NJ – July 21, 2015 – Sanofi US announced today that the company has secured broad accessibility with private insurance companies and the U.S. government for Toujeo® (insulin glargine injection) 300 Units/mL since launch. The widespread access is a result of key contracts in both the public and private sectors. Toujeo®, a once-daily, long-acting basal insulin to improve glycemic control in adults living with type 1 or type 2 diabetes, was launched in the U.S. on March 30, 2015, following U.S. Food and Drug Administration (FDA) approval in February 2015.

 Toujeo® has received preferred coverage for 9 out of 10 Medicare patients, allowing senior Americans access to this new treatment option. In addition, 73 percent of commercial plans offer unrestricted coverage of Toujeo®. These plans, which represent all employer-sponsored or privately-purchased plans, provided health insurance to more than 201 million Americans in 2013, according to the U.S. Census Bureau.

 “Sanofi US recognizes the importance of ensuring patients have access to diabetes treatments, and we have collaborated with insurance companies, the U.S. government, healthcare professionals and others to ensure access to Toujeo® for adults living with diabetes,” said Andrew Purcell, Vice President and Head of the U.S. Diabetes Business Unit, Sanofi US. “We are proud of the progress we’ve made to date and will remain steadfast in our efforts to continue expanding the availability of Toujeo®.”

 Sanofi also recently announced the initiation of the Real Life Setting study to continue reviewing the use of Toujeo® in a standard care setting, along with additional measures relating to patient experience and health resource utilization. The Real Life Setting study is a Phase IV program that will enroll 5,000 people living with diabetes in the U.S. and in Europe. This program – comprised of ACHIEVE CONTROL (U.S.), REACH CONTROL and REGAIN CONTROL studies – will compare the clinical effectiveness of Toujeo® with the standard of care using other basal insulins, along with measures related to patient satisfaction and persistence, and resource usage. Initial results of the study are expected in 2017 and results from an extended follow-up period are anticipated in 2018.

 To help support patients taking Toujeo®, Sanofi US offers the Toujeo® COACH program, which provides patients with tailored, continuous support at no additional cost. For more information about the Toujeo® COACH program, please visit www.toujeo.com/support.

 What is Toujeo®?

Prescription Toujeo® is a long-acting insulin used to control blood sugar in adults with diabetes mellitus.

·         Toujeo® contains 3 times as much insulin in 1 mL as standard insulin (100 Units/mL)

·         Toujeo® is not for use to treat diabetic ketoacidosis

·         Toujeo® should not be used in children

 Important Safety Information for Toujeo® (insulin glargine injection) 300 Units/mL

Do not take Toujeo® if you have low blood sugar or if you are allergic to insulin or any of the ingredients in Toujeo®.

Please see additional Important Safety Information for Toujeo® on the next page.
Please see link below for Full Prescribing Information for Toujeo

Important Safety Information for Toujeo® (insulin glargine injection) 300 Units/mL

Do NOT reuse needles or share insulin pens even if the needle has been changed. 

Before starting Toujeo®, tell your doctor about all your medical conditions, including if you have liver or kidney problems, if you are pregnant or planning to become pregnant or if you are breastfeeding or planning to breastfeed.

Heart failure can occur if you are taking insulin together with certain medicines called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Toujeo® Your treatment with TZDs and Toujeo® may need to be changed or stopped by your doctor if you have new or worsening heart failure. Tell your doctor if you have any new or worsening symptoms of heart failure, including:

·         Shortness of breath

·         Swelling of your ankles or feet

·         Sudden weight gain

Tell your doctor about all medications you take, including OTC medicines, vitamins, and supplements, including herbal supplements.

Toujeo® should be taken at the same time once a day. Test your blood sugar levels daily while using insulin, including Toujeo®. Do not make changes to your dose or type of insulin without talking to your doctor. Verify you have the correct insulin before each injection. Your dose for Toujeo® may be different from other insulins you have taken. Any change of insulin should be made cautiously and only under medical supervision.

Do NOT dilute or mix Toujeo® with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Use Toujeo® only if the solution is clear and colorless with no particles visible.

While using Toujeo®, do not drive or operate heavy machinery until you know how Toujeo® affects you. Don’t drink alcohol or use other medicines that contain alcohol.

The most common side effect of any insulin, including Toujeo®, is low blood sugar (hypoglycemia), which may be serious and can be life-threatening. Severe hypoglycemia may cause harm to your heart or brain. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision.

Toujeo® may cause serious side effects that can lead to death, such as severe allergic reactions. Get medical help right away if you have:

·         A rash over your whole body

·         Extreme drowsiness,

·         Shortness of breath dizziness, or confusion

·         Swelling of your face, tongue,

Please see additional Important Safety Information for Toujeo® on the next page.

Please see link below for Full Prescribing Information for Toujeo®

Important Safety Information for Toujeo® (insulin glargine injection) 300 Units/mL

·         Trouble breathing or throat

·         Fast heartbeat

·         Sweating

 Toujeo® may have additional side effects including swelling, weight gain, low potassium, and injection site reactions which may include change in fat tissue, skin thickening, redness, swelling, and itching.

Toujeo® SoloStar® is a disposable prefilled insulin pen. Talk to your doctor about proper injection technique and follow instructions in the Instruction Leaflet that comes with the pen.

Please click here for full Prescribing Information for Toujeo®: http://products.sanofi.us/Toujeo/Toujeo.pdf

About Sanofi Diabetes

Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices including blood glucose monitoring systems. Sanofi markets injectable, inhaled and oral medications for people with type 1 or type 2 diabetes.

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