Facilitating global access to diabetes treatments for non-EU patients

22 aprile 2022 – The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a recommendation for the use of two diabetes mellitus treatments, Actrapid and Insulatard, outside the European Union (EU). Actrapid and Insulatard are human insulins that have been centrally authorized in the EU since 2002. According to the EU marketing authorization, unopened insulin products must be stored in a refrigerator (2–8°C). These strict storage conditions are difficult to adhere to when temperature conditions are challenging and access to refrigeration is limited, for example in countries experiencing conflict or a humanitarian emergency situation. This adds an extra burden to the care of diabetes patients who live under these conditions. The company applied for an assessment of these two medicines with changed storage time, to include storage without refrigeration when used in countries outside the EU. Following the evaluation of stability data submitted by the company in support of their request, the CHMP concluded to allow storing the two insulin products at temperatures up to 30°C for a maximum of four weeks before they are taken into use or carried as a spare. This positive opinion by the CHMP paves the way towards increased access to treatment for diabetes patients worldwide.

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