FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Issues Concept Paper on Development of Acute Kidney Injury Drugs

July 11, 2018
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The EMA called for further discussion on ways to support the development of acute kidney injury (AKI) drugs, announcing a recommendation by the Committee for Medicinal Products for Human Use for a reflection paper on developing AKI treatments.

The paper will evaluate study designs, discuss enrollment criteria, identify important AKI risk factors and evaluate efficacy considerations, among other issues.

Currently, no drugs have been approved in the EU to treat AKI and no guidance exists to offer suggestions for AKI drug development, although there are products currently being developed.

The prevalence of AKI is increasing, especially among elderly people, and there is currently an unmet medical need for the development of products to prevent or treat the condition, the agency said.

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