Addressing heat stability of insulin products to allow for easier storage
15 November 2022
More than 50 low- and middle-income countries Focus: Diabetes
Re-evaluating the thermal stability of human insulin products and gaining regulatory approval to revise guidance and create safe conditions for flexible storage
To reduce the burden of diabetes management and the need for continuous cold storage
Diabetes is a growing problem worldwide, but especially in low- and middle-income countries (LMICs) where around three-quarters of the 527 million adults with diabetes live. As a result, access to insulin is an increasingly urgent global health priority. Current estimates show insulin is needed by more than 72 million people, yet only about half of those who depend on the lifesaving treatment have access to it. Novo Nordisk demonstrates best practice with a proactive approach to increasing access to reliable insulin products.
Addressing thermostability as a barrier to access
Standard guidance is that human insulin products must be kept cool from the moment of manufacture until the product enters use. Insulin can lose effectiveness when exposed to high temperatures, so regulatory guidance requires unopened products to be stored in a refrigerator (at 2–8°C). When infrastructure for refrigerated storage or supply chain refrigeration is unavailable or unaffordable, strict storage conditions restrict access to insulin for people with diabetes. This is particularly the case in LMICs, and in situations of humanitarian emergency and/or environments with challenging temperature conditions.
In 2021, a joint study from Médecins Sans Frontières and the University of Geneva suggested such insulins could be stored safely without refrigeration for up to four weeks. To meet the requests of these humanitarian actors, Novo Nordisk reassessed the thermal stability of its short- and intermediate-acting products Actrapid® and Insulatard®, both of which have been authorised in the EU since 2002 and are widely used in LMICs. Novo Nordisk used its data to seek a label extension and obtain a positive opinion from the European Medicines Agency. It has since updated storage guidance, which now states that its insulins can now be stored in environments of up to 30°C without refrigeration for four weeks before opening.
National submissions by Novo Nordisk to revise storage guidance in more than 50 LMICs are ongoing. The company also initiated engagements with humanitarian actors to support future use on the ground. In August 2022, Actrapid® and Insulatard® became the first human insulins to be prequalified by the World Health Organization (WHO). According to WHO, the storage guideline update will greatly facilitate the use of products where access to refrigeration is limited. Novo Nordisk is also supporting WHO’s Global Diabetes Compact by addressing thermostability as a barrier to access.
Where Novo Nordisk leads, other companies can follow. They could, for example, look at how adaptive R&D might remove barriers for the storage and administration of their products.