Sanofi Announces the CE Mark for JuniorSTAR®, a New Half-Unit Insulin Reusable Pen for People with Type 1 Diabetes
Sanofi announced today at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD), Barcelona, the CE Mark of JuniorSTAR(R), a new halfunit insulin reusable pen that can be used with Lantus(R) (insulin glargine), Apidra(R) (insulin glulisine) or Insuman(R) (recombinant human insulin). Delivering from 1 to 30 units per injection, JuniorSTAR(R) is an easy-to-use lightweight pen with a large dose display and a single-step dial back that does not leak insulin. JuniorSTAR(R) has been developed and is manufactured by Sanofi's partner Haselmeier GmbH, Stuttgart, Germany.
"Everyone deserves high-quality care while learning to manage their diabetes, for the best chances in life," said Pierre Chancel, Senior Vice President, Global Diabetes, Sanofi. "With JuniorSTAR(R), we aim to meet the needs of type 1 patients worldwide, specifically the younger ones, who need an easy-to-use pen device. This is a welcome addition to our comprehensive portfolio of established insulins, which leads the way in personalized diabetes care."
Half-unit dose increment pens provide flexibility to achieve target insulin doses especially in young patients with diabetes. JuniorSTAR(R) has been tested by people with type 1 diabetes (6 to 18 years old), parents and nurses in a non-comparative survey with 167 insulin pen users from five European countries:
- 81% of patients/parents and 86% of nurses agreed it is easy to carry on a daily basis, due to its light weight (approximately 34 grams) - 98% of patients/parents and 94% of nurses agreed it is easy to read due to its large dose display and legible numbers - Additionally, 91% of patients/parents and 89% of nurses agreed that dialling back was easy due to its single-step dial back, a feature that avoids insulin leakage - Overall, 93% of survey participants agreed on its ease of use.
A rising number of people with type 1 diabetes are being diagnosed worldwide at an increasingly younger age. People with diabetes deserve the best support to meet their needs and Sanofi is committed to providing efficient and simplified care to lighten the lives of young people living with type 1 diabetes with a comprehensive treatment portfolio, which includes established insulins, optimized insulin pens, innovative blood glucose monitoring systems and tailored patient support.
JuniorSTAR(R) meets the new ISO 11608-1 2012 standard, passed all requirements for robustness and dose accuracy, and is in three different colors (blue, red and silver) for flexibility and insulin differentiation.
JuniorSTAR(R) is expected to become available in Europe during 2014.
Diabetes is a chronic disease that occurs as type 1 diabetes, which is an autoimmune disease characterized by the lack of insulin (the hormone that regulates blood glucose concentrations) production by the pancreas, and type 2, a metabolic disorder in which there are two main biological defects: a deficient production of insulin and reduced ability of the body to respond to the insulin being produced. Type 1 and type 2 diabetes are characterized by an increase in blood glucose concentrations (hyperglycemia). Over time, uncontrolled hyperglycemia leads to the macrovascular and microvascular complications of diabetes. Macrovascular complications, which affect the large blood vessels, include heart attack, stroke and peripheral vascular disease. Microvascular complications affect the small blood vessels of the eyes (retinopathy), kidney (nephropathy) and nerves (neuropathy). The global incidence of diabetes is growing at an alarming rate, with more than 371 million people worldwide living with the condition today.
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 both injectable and oral medications for people with type 1 or type 2 diabetes.
Sanofi, a global and diversified 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 and in New York .
Haselmeier is a leading designer and manufacturer of pen and auto-injection systems. The Company's devices feature unique function, design and technology and are marketed by leading pharmaceutical and biotechnology companies around the world. For more information please visit http://www.haselmeier.com.
1) Klonoff D et al., Evaluation of the JuniorSTAR(R) half-unit insulin pen in young people with type 1 diabetes - user perspectives. European Endocrinology. 2013; 9(2):82-5. 2) International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: 2012 update. Brussels, Belgium, 2011. http://www.idf.org/diabetesatlas (accessed: June, 2013)
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