CE Mark approval for Sanofi\'s half-unit insulin reusable pen

Published: 1-Oct-2013

Easy-to-use lightweight pen offers large dose display and a single-step dial back


Sanofi has announced European CE Mark approval for its JuniorSTAR, a new half‑unit insulin reusable pen that can be used with Lantus (insulin glargine), Apidra (insulin glulisine) or Insuman (recombinant human insulin).

Delivering from 1 to 30 units per injection, JuniorSTAR is an easy-to-use lightweight pen with a large dose display and a single-step dial back that does not leak insulin. It has been developed and is manufactured by Sanofi’s partner, Haselmeier of Germany.

 

Everyone deserves high-quality care while learning to manage their diabetes, for the best chances in life

“Everyone deserves high-quality care while learning to manage their diabetes, for the best chances in life,” said Pierre Chancel, senior vice president of global diabetes at Sanofi."

"With JuniorSTAR, 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 personalised diabetes care.”

 

Half-unit dose increment pens provide flexibility to achieve target insulin doses especially in young patients with diabetes. JuniorSTAR has been tested by people with type 1 diabetes (six to 18 years old), parents and nurses in a non-comparative survey with 167 insulin pen users from five European countries. The findings include:

  • 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
 

JuniorSTAR meets the new ISO 11608-1 2012 standard, passed all requirements for robustness and dose accuracy, and is available in three different colors (blue, red and silver) for flexibility and insulin differentiation.

 

It is expected to become available in Europe during 2014.

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