FDA Approves Sanofi's Admelog® (insulin lispro injection)

First FDA-approved follow-on mealtime insulin

Admelog (insulin lispro injection) 100 Units/mL will be available in U.S. in vial and SoloStar pen

PARIS, France I December 11, 2017 I The U.S. Food and Drug Administration (FDA) has approved Sanofi's Admelog®, the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime.

"Sanofi has a deep heritage and broad experience in providing treatments for people living with diabetes. Complementing our existing insulin portfolio, Admelog will offer a more affordable option for those who require control of their blood sugar levels at mealtime," said Stefan Oelrich, Executive Vice President and Head, Global Diabetes and Cardiovascular, Sanofi. "The approval of Admelog is an important milestone for Sanofi in our mission to serve patients living with chronic diseases such as diabetes."

Admelog is a rapid-acting insulin similar to Humalog®, another insulin lispro 100 Units/mL, currently approved in the U.S. The Admelog clinical development program involved more than 1,000 adults living with type 1 or type 2 diabetes. Admelog will be available in both vials and the SoloStar pen, which is the most-used disposable insulin pen platform in the U.S.

Admelog was also granted marketing authorization as a biosimilar, under the proprietary name, Insulin lispro Sanofi®, by the European Commission in July 2017.

What is Admelog (insulin lispro injection)?

Prescription Admelog is a fast-acting human insulin used to improve blood sugar control in adults with Type 2 diabetes and adults and children (3 years and older) with Type 1 diabetes.

Important Safety Information for Admelog (insulin lispro injection)

Do not use Admelog if you have low blood sugar or if you are allergic to insulin lispro or any of the other ingredients in Admelog.

Before starting Admelog, 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 pills 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 Admelog. Your treatment with TZDs and Admelog 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, including:

•          Shortness of breath

•          Sudden weight gain

•          Swelling of your ankles or feet

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

When used as a mealtime insulin, Admelog should be taken within 15 minutes before a meal or immediately after a meal. Test your blood sugar levels as directed by your doctor when using Admelog. Do not change your dose or type of insulin without talking to your doctor. Any change of insulin should be made cautiously and only under medical supervision.

Do not share needles, insulin pens, or syringes with others, even if the needle is changed. Do NOT reuse needles.

Check your insulin label to verify that you have the correct insulin before each injection. Admelog must only be used if the solution is clear and colorless with no particles visible.

While using Admelog, do not drive or operate heavy machinery until you know how Admelog affects you. Do not drink alcohol or use medicines that contain alcohol.

The most common side effect of any insulin, including Admelog, is low blood sugar (hypoglycemia), which may be serious and life-threatening. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision.

Admelog may cause severe allergic reactions that can lead to death. Get medical help right away if you have:

•          A rash over your whole body

•          Trouble breathing

•          Fast heartbeat

•          Feeling faint

•          Sweating

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

Important Safety Information for Admelog (insulin lispro injection) SoloStar

Admelog 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 see full Prescribing Information.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

SOURCE: Sanofi

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