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EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.
Novo Nordisk announced on April 22, 2022 that the European Medicines Agency (EMA) has issued the company a positive scientific opinion for a proposed update to the storage conditions of two human insulins.
The more flexible storage conditions will allow Actrapid (short-acting insulin) and Insulatard (intermediate-acting insulin) to be stored for four weeks outside of a refrigerator, if kept below 30 oC, prior to use if there are six months or more until the expiry date. The insulin should be stored without refrigeration once in use.
EMA’s positive scientific opinion will be used to support the flexibility and convenience for many people with diabetes in low- and middle-income countries who have limited access to reliable refrigeration or live within long distances from a clinic or pharmacy.
Insulin is temperature-sensitive and loses potency when exposed to temperatures that are too high or too low. This can be an issue for sufficient cold storage in hot climates or in areas without reliable refrigeration or electricity. Thermostability of insulin is important to maintain more accessibility to patients with diabetes globally.
“For patients receiving insulin therapy, maintaining insulin within recommended temperatures can be a source of anxiety, challenge, and poor compliance and it is not always possible to find a solution,” said Dr. Kaushik Ramaiya, honorary general secretary, Tanzania Diabetes Association, in a press release. “Creating new opportunities for established products to benefit people with diabetes in resource-constrained settings is a recognizable contribution to help address unmet needs of majority of the people with diabetes in low- and middle-income countries.”
Source: Novo Nordisk