Novo Nordisk (NYSE:NVO) announced that the European Medicines Agency (EMA) granted a positive opinion on a storage update for insulin.
EMA’s positive opinion relates to a proposed update to the storage conditions of two human insulins: Actrapid (short-acting insulin) and Insulatard (intermediate-acting insulin).
Bagsværd, Denmark-based Novo Nordisk said in a news release that the EMA’s positive opinion will be used to support obtaining approval of the more flexible storage conditions by national health authorities in several low- and middle-income countries.
The company seeks approval for Actrapid and Insulatard to 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.
Novo Nordisk said this flexibility aims to improve the 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.
“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,” Novo Nordisk EVP of Development Martin Holst Lange said in the release. “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.”
