Friedrich Mittermayer*, Erica Caveney, Claudia De Oliveira, G. Alexander Fleming, Loukas Gourgiotis, Mala Puri, Li-Jung Tai and J. Rick Turner Pages 300 - 314 ( 15 )
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 β-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.
Type 1 diabetes, new drug development, regulatory environment, FDA, EMA, new mechanisms of action, insulins; anti-inflammatory drugs, immunomodulatory, islet regeneration.
Quintiles GmbH, Stella-Klein-Löw Weg 15, Rund 4, Haus B, OG 4, 1020 Vienna, Diabetes Center of Excellence, Quintiles, Durham, NC, Cardiovascular and Metabolic Diseases, Quintiles, Durham, NC, Kinexum, Harpers Ferry, WV, Cardiovascular and Metabolic Diseases, Quintiles, Reading, Cardiovascular and Metabolic Diseases, Quintiles, Durham, NC, Ionis Pharmaceuticals, Carlsbad, CA, Diabetes Center of Excellence, Quintiles, Durham, NC