LAVAL, QC, June 1, 2015 /CNW Telbec/ - Sanofi Canada, the manufacturer of Lantus®, is proud to announce that Health Canada has approved Toujeo™ (insulin glargine [rDNA origin] injection, 300 U/mL) indicated as a once-daily long-acting basal insulin for reaching glycemic control in adults living with type 1 and type 2 diabetes mellitus. Toujeo™ is expected to be available in Canada at the beginning of Q3 2015.
"Nearly 50 percent of people treated with insulin injections for their diabetes are not achieving their glycemic goals," said Dr. Stewart Harris, Professor at the Schulich School of Medicine at Western University London, Ontario. "Ensuring appropriate intensification and adherence to treatment can be a challenge for both patients and healthcare professionals due to various factors such as hypoglycemia concerns. Toujeo is a new basal insulin option that may help patients to better manage their diabetes and achieve their glycemic goal."
Optimal glycemic control is fundamental to the management of diabetes. Therapy in most individuals with type 1 or type 2 diabetes should be targeted to achieve an A1C ≤7.0% to reduce the risk of microvascular and, if implemented early in the course of disease, macrovascular complications.1
"We are excited to offer people living with diabetes and their Health Care Professionals a new treatment option to help them better manage their condition," claims Martin Arès, Vice-President, Diabetes and Cardiovascular Business Unit. "Sanofi has over eighty-five years of history in the treatment of diabetes. Toujeo is the result of our ongoing drive and innovation to improve insulin therapy. It offers healthcare professionals and people living with diabetes a new solution to reach and maintain their health goals."
Health Canada's approval of Toujeo™ is based on the review of results from the EDITION clinical trial program, a series of international Phase III studies evaluating the efficacy and safety of Toujeo™ compared with Lantus® (insulin glargine [rDNA origin] injection, 100 U/mL) in more than 3,500 adults from broad and diverse diabetes populations (type 1 and type 2) who were uncontrolled on their current therapy.2-7 In the clinical trial program leading to approval, once-daily Toujeo™ was compared to that of once-daily Lantus® (insulin glargine [rDNA origin] injection, 100 U/mL) in open-label, randomized, active-control, parallel, treat-to-target studies of up to 26 weeks of duration with 6 months safety extension.
Toujeo™ will be available in the Toujeo™ SoloSTAR®, disposable prefilled pen. The pen contains 450 units of insulin glargine. Unopened Toujeo™ SoloSTAR® pens must be kept refrigerated between 2 °C and 8 °C. After first use, Toujeo™ SoloSTAR® pens can be kept at room temperature up to 42 days (six weeks). The Toujeo™ SoloSTAR® requires one third of the injection volume to deliver the same number of insulin units as compared to the Lantus® SoloSTAR®. The maximum single injection dose is 80 units.
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.8-13 In addition, optimal insulin dose is often not reached during initiation or maintenance phase. 14
Toujeo™ [insulin glargine injection (rDNA origin)] a new basal insulin treatment option is indicated for once-daily subcutaneous administration in the treatment of adult patients (≥18 years) with type 1 or type 2 diabetes mellitus who require basal (long-acting) insulin for glycemic control.15 Toujeo™ provides a constant glucose lowering effect throughout a 24-hour period.14
Results from the EDITION clinical trials demonstrated that, in a treat to target design, Toujeo™ achieves comparable glycemic control to Lantus®. Toujeo™ has a similar safety profile to Lantus®. Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Toujeo™. The most common adverse events (regardless of causality) reported for Toujeo™ and Lantus® in type 1 and type 2 diabetes patients included nasopharyngitis, upper respiratory tract infection and headache.15
Toujeo™ will be available in the Toujeo™ SoloSTAR®, disposable prefilled pen. The pen contains 450 units of insulin glargine, and it can be kept at room temperature up to 42 days (6 weeks) after first use. Unopened Toujeo™ SoloSTAR® pens must be kept refrigerated between 2 °C and 8 °C. The Toujeo™ SoloSTAR® requires one third of the injection volume to deliver the same number of insulin units as compared to the Lantus® SoloSTAR®. The maximum single injection dose is 80 units.
About Sanofi – www.sanofi.ca
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).
Sanofi entities in Canada include Sanofi Canada (pharmaceuticals), Sanofi Pasteur (vaccines), Sanofi Consumer Health (cosmeceuticals, over-the-counter products and specialty care), Genzyme (rare diseases) and Merial (animal health). Together they employ close to 1,700 people. In 2014, Sanofi companies invested $130.5 million in R&D in Canada, creating jobs, business and opportunity throughout the country.
1. Canadian Diabetes Association 2013 Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada - Available at: http://www.diabetes.ca/clinical-practice-education/clinical-practice-guidelines#sthash.dWAQa4O4.dpuf
2. Riddle MC, et al. Diabetes Care. 2014;37(10):2755-62. DOI: 10.2337/dc14-0991.
2. Yki-Järvinen H, et al. Diabetes Care. 2014;37(12):3235-43. DOI: 10.2337/dc14-0990.
3. Bolli GB, et al. Diabetes Obes Metab. 2015:epub ahead of print. DOI: 10.1111/dom.12438.
4. Home P, et al. Oral presentation abstract #148 presented at EASD, Vienna, September 15–19, 2014. Available from http://www.easdvirtualmeeting.org/resources/16864 . Date accessed: April 2015.
5. Matsuhisa M, et al. ePoster abstract #975 presented at EASD, Vienna, September 15–19, 2014. Available from http://www.easdvirtualmeeting.org/resources/17806. Date accessed: April 2015.
6. Terauchi Y, et al. ePoster abstract #976 presented at EASD, Vienna, September 15–19, 2014. Available from http://www.easdvirtualmeeting.org/resources/17807. Date accessed: April 2015.
7. Ritzel RA, Roussel R, Bolli GB et al. New insulin glargine 300 U/ml: glycaemic control and hypoglycaemia in a meta-analysis of phase 3a EDITION clinical trials in people with type 2 diabetes mellitus. Poster at European Association for the Study of Diabetes congress, 2014, abstract 963.
8. Banegas JR, et al. Eur Heart J. 2011;32(17):2143-52. DOI: 10.1093/eurheartj/ehr080.
9. Stark Casagrande S, et al. Diabetes Care. 2013;36(8):2271-9. DOI: 10.2337/dc12-2258.
10. Chan JCN, et al. Diabetes Care. 2009;32(2):227-33. DOI: 10.2337/dc08-0435.
11. Choi YJ, et al. Diabetes Care. 2009;32(11):2016-20. DOI: 10.2337/dc08-2228.
12. Steinberg BA, et al. American Heart Journal. 2008;156(4):719-27. DOI: 10.1016/j.ahj.2008.05.020.
13. Vouri SM, et al. Journal of managed care pharmacy : JMCP. 2011;17(4):304-12.
14. Harris S. et al. Can Fam Physician. 2010: 56(12):e418-24
15. Sanofi Canada Toujeo™SoloSTAR® Product Monograph 2015.
SOURCE Sanofi Canada
For further information: Catherine R. Cunningham, Sanofi Canada, Tel: 514-956-6120, [email protected]