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Regulatory Focus™ > News Articles > 7 > EMA Drafts Concept Paper on Acute Kidney Injury Drugs

EMA Drafts Concept Paper on Acute Kidney Injury Drugs

Posted 09 July 2018 | By Michael Mezher 

EMA Drafts Concept Paper on Acute Kidney Injury Drugs

The European Medicines Agency (EMA) on Monday released a concept paper discussing the need for further efforts to support the development of drugs to prevent and treat acute kidney injury.

Acute kidney injury is a serious condition marked by an acute decline in kidney function that can be caused by a host of factors, including kidney disease, drug induced kidney toxicity and certain medical interventions. Acute kidney injury is a common complication among intensive care unit patients and is increasingly prevalent as populations in in Europe age.

While there have been products in development to prevent or treat acute kidney injury and its complications, none have been authorized in the EU or US. There are also no guidance documents on the development of drugs to treat or prevent acute kidney injury developed by EMA or the International Council for Harmonisation (ICH).

EMA says there is a need to develop a reflection paper that summarizes and consolidates the agency's regulatory and scientific experience with acute kidney injury that provides recommendations for the development of products to treat or prevent the condition.

According to EMA, the reflection paper will cover issues related to acute kidney injury in different patient populations and clinical settings, clinical study designs to evaluate efficacy, assessing safety and other methodological issues, such as risk factors related to acute kidney injury that could confound study results.

EMA also says the discussion paper will discuss issues related to pediatric extrapolation, and whether full or partial extrapolation is possible, and if not, whether alternative strategies can be used to support pediatric use.

EMA is currently soliciting input on the concept paper through March 2019 and says that it plans to host workshops with industry and nephrology experts before issuing a draft reflection paper for consultation by Q1 2020.

Concept Paper


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