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

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

SUBMITTER: Blind E 

PROVIDER: S-EPMC6667915 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature