The European Medicines Agency's approval of new medicines for type 2 diabetes
| Autor: | Heidi Janssen, Eberhard Blind, Kristina Dunder, Pieter A. de Graeff |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Glucose control Endocrinology Diabetes and Metabolism Review Article Type 2 diabetes 030204 cardiovascular system & hematology 03 medical and health sciences 0302 clinical medicine Endocrinology systematic review Agency (sociology) Internal Medicine Humans Hypoglycemic Agents Insulin Medicine 030212 general & internal medicine Intensive care medicine Review Articles Drug Approval antidiabetic drug Cardiovascular safety business.industry International Agencies medicine.disease drug development Europe Principal (commercial law) Diabetes Mellitus Type 2 Drug development Cardiovascular Diseases business Insulin products |
| Zdroj: | Diabetes, Obesity & Metabolism |
| ISSN: | 1462-8902 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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