April 22, 2022
EMA’s human medicines committee (CHMP) has given a recommendation for two diabetes mellitus treatments, Actrapid and Insulatard, for use outside the European Union (EU).
EMA is committed to supporting global regulatory capacity building and contributing to the protection and promotion of public health beyond the EU by assessing medicines for countries with limited regulatory resources. The two diabetes medicines were submitted to EMA under a regulatory procedure (Article 58 of Regulation (EC) No 726/2004) known as EU Medicines for all (EU-M4All).
This allows the Agency to assess the quality, safety and efficacy of medicines that address unmet medical needs or are of major public health interest for use outside the EU, and give an opinion on their benefit-risk balance, taking into account the context of their use in target populations and any specific requirement in certain low- and middle-income countries outside the EU. Medicines submitted under this program are assessed by EMA in collaboration with experts from the World Health Organization (WHO) and the target countries. Any medicine assessed under this procedure must meet the same standards as medicines intended for EU citizens.
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.
Diabetes is a chronic disease in which the body does not produce enough insulin to control the blood glucose (type-1 diabetes) or when the body is unable to use insulin effectively (type-2 diabetes). Insulin is a hormone that regulates blood sugar. Raised blood sugar is a common effect of uncontrolled diabetes and over time leads to serious damage to many of the body's systems, causing blindness, kidney failure, heart attacks, stroke and lower limb amputation. Left untreated, type-1 diabetes can be a life-threatening condition. According to the WHO, in 2019 diabetes was the ninth leading cause of death with an estimated 1.5 million deaths directly caused by this disease. Prevalence has been rising more rapidly in low- and middle-income countries than in high-income countries.
Actrapid and Insulatard are the thirteenth and fourteenth medicines to receive an EMA recommendation under EU Medicines for all (EU-M4All). Experts from the WHO and regulators from Bangladesh, India, Iraq and Zambia were invited to follow the evaluation as observers. This helps to ensure that specific disease expertise and local knowledge are taken into account.
National regulators can use the CHMP's scientific assessment to decide on the use of these medicines in their countries.
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