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.