Abstract
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.Keywords: Type 1 diabetes, new drug development, regulatory environment, FDA, EMA, new mechanisms of action, insulins; anti-inflammatory drugs, immunomodulatory, islet regeneration.
Current Diabetes Reviews
Title:Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development
Volume: 13 Issue: 3
Author(s): Friedrich Mittermayer*, Erica Caveney, Claudia De Oliveira, G. Alexander Fleming, Loukas Gourgiotis, Mala Puri, Li-Jung Tai and J. Rick Turner
Affiliation:
- Quintiles GmbH, Stella-Klein-Löw Weg 15, Rund 4, Haus B, OG 4, 1020 Vienna,Austria
Keywords: Type 1 diabetes, new drug development, regulatory environment, FDA, EMA, new mechanisms of action, insulins; anti-inflammatory drugs, immunomodulatory, islet regeneration.
Abstract: 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.Export Options
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Cite this article as:
Mittermayer Friedrich*, Caveney Erica, De Oliveira Claudia, Fleming Alexander G., Gourgiotis Loukas, Puri Mala, Tai Li-Jung and Turner Rick J., Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development, Current Diabetes Reviews 2017; 13 (3) . https://dx.doi.org/10.2174/1573399812666160413115655
DOI https://dx.doi.org/10.2174/1573399812666160413115655 |
Print ISSN 1573-3998 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-6417 |
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