Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development

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:

• Diabetes Center of Excellence, Quintiles, Durham, NC,United States

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.

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