Journal
CURRENT DIABETES REVIEWS
Volume 13, Issue 3, Pages 300-314Publisher
BENTHAM SCIENCE PUBL LTD
DOI: 10.2174/1573399812666160413115655
Keywords
Type 1 diabetes; new drug development; regulatory environment; FDA; EMA; new mechanisms of action; insulins; anti-inflammatory drugs; immunomodulatory; islet regeneration
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Introduction: The incidence of type 1 diabetes (T1D) is increasing worldwide and there is a very large need for effective therapies. Essentially no therapies other than insulin are currently approved for the treatment of T1D. Drugs already in use for type 2 diabetes and many new drugs are under clinical development for T1D, including compounds with both established and new mechanisms of action. Content of the Review: Most of the new compounds in clinical development are currently in Phase 1 and 2. Drug classes discussed in this review include new insulins, SGLT inhibitors, GLP-1 agonists, immunomodulatory drugs including autoantigens and anti-cytokines, agents that regenerate beta-cells and others. Regulatory Considerations: In addition, considerations are provided with regard to the regulatory environment for the clinical development of drugs for T1D, with a focus on the United States Food and Drug Administration and the European Medicines Agency. Future opportunities, such as combination treatments of immunomodulatory and beta-cell regenerating therapies, are also discussed.
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