Sanofi : Toujeo® Receives Positive Opinion from the European Regulatory Authorities

Paris, France - February 27, 2015 -Sanofi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL), a next-generation basal insulin for the treatment of adults with type 1 and type 2 diabetes. Toujeo has demonstrated a more stable and a prolonged glycemic control that lasts beyond 24 hours compared with Lantus® (insulin glargine [rDNA origin] injection, 100 U/mL) with low within-individual, within-day blood sugar variability.1-3

"Today's CHMP opinion is another step forward to make Toujeo available to people living with diabetes who are currently not at their glycemic target, or are about to start insulin therapy," said Pierre Chancel, Senior Vice President, Global Diabetes, Sanofi. "We are confident that we can soon add this new treatment option to our portfolio to help patients reach their blood sugar goals."

The CHMP positive opinion of Toujeo is based on results from the EDITION clinical trial program, a worldwide and extensive series of Phase III studies evaluating the efficacy and safety of Toujeo compared to Lantus in more than 3,500 adults with type 1 or type 2 diabetes who were uncontrolled on their current therapy.4-9 Toujeo demonstrated effective blood sugar control, with a favorable safety profile. Toujeo significantly lowered hypoglycemic (low blood sugar) risk in people with type 2 diabetes both at any time of the day and night-time compared with Lantus.10

The European Commission (EC) is expected to make a final decision on granting marketing authorization for Toujeo in the EU in the coming months. Toujeo was approved by the U.S. Food and Drug Administration and is under review by other regulatory authorities around the world.

Once approved, Toujeo will be available in the Toujeo SoloSTAR®, a disposable prefilled pen which contains 450 insulin units (IU), and it has a maximum single injection dose of 80 IU.

About Toujeo
Despite basal insulin being a cornerstone treatment for diabetes for decades, significant unmet medical needs remain a reality, with approximately half of patients on treatment not reaching their blood sugar level targets.11-16 In addition, optimal insulin dose is often not reached during initiation or maintenance phase. Toujeo is a next-generation, once-daily basal insulin based on a broadly-used molecule (insulin glargine) with a well-established benefit-risk profile.17 Its compact subcutaneous depot leads to more stable and more prolonged pharmacokinetic/pharmacodynamic (PK/PD) profiles. 1-3

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.

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

References

1.      Steinstraesser A, Schmidt R, Bergmann K, et al. Diabetes, Obesity and Metabolism. 2014;16(9):873-6, DOI: 10.1111/dom.12283.
2.      Becker RHA, Dahmen R, Bergmann K, et al. Diabetes Care. 2014:epub ahead of print, DOI: 10.2337/dc14-0006.
3.      Shiramoto M, Eto T, Irie S, et al. Diabetes, Obesity and Metabolism. 2014:epub ahead of print, DOI: 10.1111/dom.12415.
4.      Riddle MC, Bolli GB, Ziemen M, et al. Diabetes Care. 2014;37(10):2755-62, DOI: 10.2337/dc14-0991.
5.      Yki-Järvinen H, Bergenstal R, Ziemen M, et al. Diabetes Care. 2014;37(12):3235-43, DOI: 10.2337/dc14-0990.
6.      Bolli GB, Riddle MC, Bergenstal RM, et al. Diabetes, Obesity and Metabolism. 2015:epub ahead of print, DOI: 10.1111/dom.12438.
7.      Home P, Bergenstal R, Riddle M, et al.  50th Annual Meeting of the European Association for the Study of Diabetes (EASD)2014.  Oral presentation abstract #148.
8.      Matsuhisa M, Koyama M, Cheng X, et al.  50th Annual Meeting of the European Association for the Study of Diabetes (EASD)2014.  Poster abstract #975.
9.      Terauchi Y, Koyama M, Cheng X, et al.  50th Annual Meeting of the European Association for the Study of Diabetes (EASD)2014.  Poster abstract #976.
10.    Ritzel R, Roussel R, Bolli G, et al.  50th Annual Meeting of the European Association for the Study of Diabetes (EASD)2014.  Poster abstract #963.
11.    Banegas JR, López-García E, Dallongeville J, et al. Eur Heart J. 2011;32(17):2143-52, DOI: 10.1093/eurheartj/ehr080.
12.    Stark Casagrande S, Fradkin JE, Saydah SH, et al. Diabetes Care. 2013;36(8):2271-9, DOI: 10.2337/dc12-2258.
13.    Chan JCN, Gagliardino JJ, Baik SH, et al. Diabetes Care. 2009;32(2):227-33, DOI: 10.2337/dc08-0435.
14.    Choi YJ, Kim HC, Kim HM, et al. Diabetes Care. 2009;32(11):2016-20, DOI: 10.2337/dc08-2228.
15.    Steinberg BA, Bhatt DL, Mehta S, et al. American Heart Journal.156(4):719-27, DOI: 10.1016/j.ahj.2008.05.020.
16.    Vouri SM, Shaw RF, Waterbury NV, et al. Journal of managed care pharmacy : JMCP. 2011;17(4):304-12, DOI, http://www.ncbi.nlm.nih.gov/pubmed/21534641
17.    Gerstein HC, Bosch J, Dagenais GR, et al. The New England journal of medicine. 2012;367(4):319-28, DOI: 10.1056/NEJMoa1203858.

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