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Novo Nordisk receives positive scientific opinion from EMA

Martin Holst Lange

The European Medicines Agency (EMA) has granted the company a positive scientific opinion for a proposed update to the storage conditions of two human insulins.

EMA’s positive scientific opinion will now be used to support obtaining approval of the more flexible storage conditions by national health authorities in a number of relevant low- and middle-income countries, states the comapny. This to allow that Actrapid (short-acting insulin) and Insulatard (intermediate-acting insulin) can be stored for four weeks outside of a refrigerator (if kept below 30° C) prior to use if there are six months or more to the expiry date. Once in use, the insulin should be stored without refrigeration.

The new guidance aims to improve flexibility and convenience for many people with diabetes in low- and middle-income countries, who have limited access to reliable refrigeration, and who may live within long distances from a clinic or pharmacy, describes the company.

Defeat Diabetes

Insulin is temperature-sensitive and loses potency when exposed to too high or low temperatures. The cold storage requirement of insulin can be a challenge, especially in hot climates and in countries or humanitarian settings where people have limited access to refrigeration or reliable electricity.

The company undertook the project of investigating the safety of its human insulin at different temperatures as part of its social responsibility strategy Defeat Diabetes.

Novo Nordisk’s efforts to address thermostability as a barrier to access to care are well aligned with the asks presented to the company by humanitarian, academic and public health actors. With these efforts, Novo Nordisk also aims to support the World Health Organization’s Global Diabetes Compact and the private sector asks to industry, one of which is to collaborate to advance the thermostability agenda for insulin, they state.

“The EMA positive opinion paves the way for us to start updating the label for two human insulin products in low- and middle-income countries, to allow patients to store their insulin outside of the refrigerator for one month before use.”

“I am proud of our continuous efforts to innovate and adapt to improve access to life-saving medicines for people living with serious chronic diseases. The EMA positive opinion paves the way for us to start updating the label for two human insulin products in low- and middle-income countries, to allow patients to store their insulin outside of the refrigerator for one month before use. Looking ahead, we hope to be able to develop an actual thermostable insulin but until then, we will continue to pursue other means of addressing this barrier,” says Martin Holst Lange, executive vice president, Development at Novo Nordisk.

Photo of Martin Holst: Novo Nordisk