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FDA Expands Indication for Soliqua 100/33 (insulin glargine and lixisenatide injection) to Include Type 2 Diabetes Patients Uncontrolled on Oral Antidiabetic Medicines

BRIDGEWATER, N.J., Feb. 27, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved the expanded use of Soliqua 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL. Previously approved for use as an add-on to diet and exercise in adults with type 2 diabetes who are uncontrolled on long-acting insulin or lixisenatide, Soliqua 100/33 can now also be prescribed for patients uncontrolled on oral antidiabetic medicines.

"Many people living with type 2 diabetes are uncontrolled on diet and exercise alone and could require additional interventions to help lower their blood sugar levels," said Michelle Carnahan, North America Head of Primary Care, Sanofi. "This FDA decision marks the first combination insulin and GLP-1 injectable medicine approved for adults living with type 2 diabetes who are uncontrolled with diet and exercise, potentially providing them access to an option that can help them achieve their treatment goals."

The FDA approval was based on data from the LixiLan-O clinical trial which showed, in adults with type 2 diabetes uncontrolled with metformin and/or a second oral antidiabetic therapy, that treatment with Soliqua 100/33 led to significantly greater reductions in blood sugar levels compared with insulin glargine and lixisenatide (-1.6%, -1.3%, -0.9%, respectively; p<0.0001). In addition, significantly more patients reached their target blood sugar levels with Soliqua 100/33 (74%) compared with insulin glargine (59%) or lixisenatide (33%). Low blood sugar events were similar between Soliqua 100/33 (25.6%) and insulin glargine (23.6%), but were lower with lixisenatide (6.4%). The most common adverse events generally at the beginning of treatment in the Soliqua 100/33 arm were nausea (9.6%) and vomiting (3.2%).

Sanofi will continue offering its savings program for Soliqua 100/33 which can limit out-of-pocket expenses sometimes to $0 for all commercially insured patients regardless of formulary status on an insurance plan or income level. For more information about this program, visit www.soliqua100-33.com.

About Soliqua 100/33

Soliqua 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, which may improve blood sugar (glucose) control in adults with type 2 diabetes when used with diet and exercise.

  • It has not been studied in people with a history of pancreatitis.
  • It is not recommended for people who also take lixisenatide or other medicines called GLP-1 receptor agonists.
  • It is not for use in people with type 1 diabetes, or people with diabetic ketoacidosis.
  • It has not been studied in people who have a stomach problem that causes slow emptying (gastroparesis) and is not for people with slow emptying of the stomach.
  • It has not been studied in people who also take a short-acting (prandial) insulin.
  • It is not known if Soliqua 100/33 is safe and effective in children under 18 years of age.

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.

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, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE Sanofi

Posted: February 2019

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