Sanofi's Insulin Toujeo® now Available for the Treatment of Adults with Diabetes in the UK

GUILDFORD, England, August 4, 2015 /PRNewswire/ --

- New once-daily basal insulin demonstrated similar glycaemic control with a lower incidence of confirmed hypoglycaemia when compared to Lantus^® in the treatment of adults with type 2 diabetes^[1] -

Sanofi announced today that Toujeo^® (insulin glargine [rDNA origin] 300 units/mL), a long-acting, once-daily basal insulin treatment is available for clinicians to prescribe in the UK, providing another option for adults with type 1 and type 2 diabetes mellitus to help manage their condition. Insulin glargine 300 units/ml is indicated for the treatment of diabetes mellitus in adults^[1] and is a novel formulation of the glargine molecule Lantus^® (insulin glargine 100 units/mL) currently used in the treatment of diabetes.^[2]

There are currently 3.3 million people in the UK diagnosed with diabetes^[3] a figure predicted to rise to an estimated five million people by 2025.^[4] Over two thirds of adults treated with insulin do not reach the National Institute for Health and Care Excellence (NICE) target for blood glucose control (HbA_1c ≤ 7.5%),^[5] increasing their risk of potentially avoidable complications such as amputation, blindness and renal disease.^[4] Many clinicians cite concern of hypoglycaemia as a reason for not managing blood glucose more aggressively - three quarters (75.5%) of specialists would be more aggressive in treating diabetes if there was no concern about hypoglycaemia.^[6] For patients, concern over hypoglycaemia may cause them to modify their insulin dose - four out of ten people with type 2 diabetes reduce their insulin dose after an episode of mild hypoglycaemia and six out of ten after a severe hypoglycaemic episode.^[7]

Melanie Davies, Professor of Diabetes Medicine, University of Leicester and Honorary Consultant, University Hospitals Leicester commented: "This new basal insulin is an additional treatment option for doctors to help manage patients who are not currently able to reach optimal glycaemic control. Hypoglycaemia is one of the most frequent adverse events experienced by people treated with insulin and fear of these events can prevent some patients administering appropriate insulin doses and can even lead to discontinuation of treatment. The consequence may be poor blood glucose control and an increased risk of long-term complications."

Results from clinical trials evaluating the efficacy and tolerability of insulin glargine 300 units/mL compared to insulin glargine 100 units/mL demonstrated a similar blood glucose (HbA_1c) reduction with a lower incidence of confirmed hypoglycaemia in patients with type 2 diabetes on insulin glargine 300 units/mL compared to those on insulin glargine 100 units/ml.^[1] In patients with type 1 diabetes, trials demonstrated similar blood glucose (HbA_1c) reduction but showed no difference in confirmed hypoglycaemia.^[1] Insulin glargine 300 units/mL also showed a more stable and more prolonged glucose lowering effect that lasted beyond 24 hours, and low within-individual blood-sugar variability.^[1]

Dr David Williams, Medical Director for Sanofi UK said, "The availability of Toujeo in the UK is a significant milestone for Sanofi as we expand our portfolio of medicines for patients with both type 1 and type 2 diabetes and reinforces our commitment to continue improving the quality of diabetes care."

Insulin glargine 300 units/mL was licensed by the European Medicines Agency (EMA) in February 2015. It has also been licensed by the U.S. Food and Drug Administration (FDA) and is under review by other regulatory authorities around the world.

Insulin glargine 300 units/mL forms a compact subcutaneous depot with a reduced surface area^[8],[9] and allows for a slower, more prolonged release of insulin glargine beyond 24 hours.^[8]-[10] Insulin glargine 300 units/mL and insulin glargine 100 units/mL are not bioequivalent and therefore are not interchangeable.^[1] Switching from once-daily insulin glargine 300 units/mL, to insulin glargine 100 units/mL results in an increased risk of hypoglycaemic events, mainly in the first week after the switch. To reduce this risk, patients should reduce their dose by 20%. When switching to or from insulin glargine 300 units/mL, close metabolic monitoring is recommended during the transition and in the initial weeks thereafter.^[1]

For more information about insulin glargine 300 units/mL and for its side effect profile please refer to the Summary of Products Characteristics.

About Diabetes in the UK 

There are 3.3 million people in the UK currently diagnosed with diabetes^[3] and this is predicted to rise to an estimated five million people by 2025.^[4] The estimated split between people with type 2 and type 1 diabetes is 90:10. Additionally, it is believed that there are approximately 630,000 people in the UK who have diabetes but do not know it.^[4] The NHS spends around £10 billion (10 per cent of its total budget) on diabetes; that's about £1 million every hour.^[4] When including the indirect costs associated with managing people with diabetes in the UK the overall cost is estimated at £23.7 billion and is predicted to rise to almost £40 billion by 2035/6.^[11]

About the EDITION Study Programme 

EDITION results demonstrated that insulin glargine 300 units/mL, when compared to insulin glargine 100 units/mL conferred:^[1]

• Non-inferior blood glucose control in adult type 1 and type 2 diabetes over the six month study period
• Lower incidence of confirmed hypoglycaemia (at any time of the day and nocturnal) in type 2 diabetes over the six month study period
  • Confirmed hypoglycaemia:
    • 11% relative risk reduction (relative risk (RR): 0.89 [95% confidence interval (CI): 0.83 to 0.96], absolute risk (AR) 57.6% vs 64.5%, [absolute risk reduction (ARR): 6.9%]) for those treated in combination with non-insulin anti-hyperglycaemic medicinal product
    • 7% relative risk reduction (RR: 0.93 [95% CI: 0.88 to 0.99], AR 81.9% vs 87.8%, [ARR: 5.9%]) for those treated in combination with a mealtime insulin (+/- metformin)
• No significant difference in severe hypoglycaemia (at any time of the day and nocturnal) in type 2 diabetes over the six month study period:
  • Severe hypoglycaemia:
    • 18% relative risk reduction (RR: 0.82 [95% CI: 0.33 to 2.00], AR 1.0% vs 1.2%, [ARR: 0.2%]) for those treated in combination with non-insulin anti-hyperglycaemic medicinal product
    • 13% relative risk reduction (RR: 0.87 [95% CI: 0.48 to 1.55], AR 5.0% vs 5.7%, [ARR: 0.7%]) for those treated in combination with a mealtime insulin (+/- metformin)
• Reduced risk of nocturnal hypoglycaemia in type 2 diabetes from week nine to the end of the study period (6 months)
  • 18% relative risk reduction (RR: 0.82 [95% CI: 0.68 to 0.99], AR 18.4% vs 22.5%, [ARR: 4.1%]) for those treated in combination with non-insulin anti-hyperglycaemic medicinal product
  • 21% relative risk reduction (RR: 0.79 [95% CI: 0.67 to 0.93], AR 36.1% vs 46.0%, [ARR: 9.9%]) for those treated in combination with a mealtime insulin
• Similar incidence of hypoglycaemia in type 1 diabetes over the six month study period

About Sanofi Diabetes 

Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalised 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 both injectable 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 diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

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 and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. 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, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those 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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. 

References 

1. Toujeo (insulin glargine 300 units/mL Summary of Product Characteristics (SmPC). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000309/WC500047935.pdf. Accessed 11 June 2015
2. EMA Committee for Medicinal Products for Human Use (CHMP) Summary of Opinion. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000309/WC500183282.pdf. Accessed 11 June 2015
3. Quality and Outcomes Framework (QOF) 2013/2014
4. Diabetes UK. Diabetes Facts and Stats. Available at: http://www.diabetes.org.uk/Documents/About%20Us/Statistics/Diabetes-key-stats-guidelines-April2014.pdf. 
Accessed 11 June 2015
5. Sanofi Data on File. SAGB.DIA.14.10.0602.
6. Peyrot M et al.Diabetes Med 2012;29:682-689
7. Leiter LA et al. Can J Diabetes. 2005;29:186-192
8. Owens DR et al. Diabetes Metab Res Rev 2014; 30: 104-119
9. Shiramoto M et al. Diabetes Obes Metab. 2015 Mar;17(3):254-60
10. Becker RHA et al. Diabetes Care 2015 Apr;38(4):637-43
11. Hex N et al. Diabetic Medicine 2012. 29(7):855-862