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

PARIS, Dec. 11, 2017 /PRNewswire/ -- 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.

Sanofi, Empowering Life

 US Media Relations Investor Relations Ashleigh Koss George Grofik Tel. : +1 (908) 981-8745 Tel. : +33 (0)1 53 77 45 45 Mobile: +1 (908) 205-2572 ir@sanofi.com Ashleigh.Koss@sanofi.com 

Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the absence of guarantee that the product will be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2016. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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SOURCE Sanofi