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Review
. 2018 Sep;20(9):2059-2063.
doi: 10.1111/dom.13349. Epub 2018 May 30.

The European Medicines Agency's approval of new medicines for type 2 diabetes

Eberhard Blind  1 , Heidi Janssen  1 , Kristina Dunder  2 , Pieter A de Graeff  3
Affiliations
Review

The European Medicines Agency's approval of new medicines for type 2 diabetes

Eberhard Blind et al. Diabetes Obes Metab. 2018 Sep.

Abstract

Since 2005, more than 40 new medicines for the treatment of type 2 diabetes have been introduced on the market. These consist of 15 new active substances establishing three new classes of non-insulin products, and several new or modified insulin products and combinations. The approval of these products in Europe is regulated via the centralized procedure at the European Medicines Agency. Demonstration of benefit with regard to improved glucose control remains the principal outcome required from confirmatory studies to demonstrate efficacy. For the majority of these new medicines approved since 2005, cardiovascular outcome trials have now been completed, and have invariably supported the cardiovascular safety of these products. In some of these trials additional important benefits have been observed, for instance, a reduction in major adverse cardiovascular events and improvement of renal outcome. The existing regulatory framework and the continuous adaption of regulatory requirements to emerging developments will continue to guide the approval of new products in the future.

Keywords: antidiabetic drug; drug development; systematic review.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Approval of new products for the treatment of type 2 diabetes since 2005
Figure 2
Figure 2
Approval of new active substances (non‐insulin only) for the treatment of type 2 diabetes
See this image and copyright information in PMC

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