The journey of an antidiabetic drug towards approval by the international regulatory agencies. Current situation

The approval process for new antidiabetic drugs has been radically transformed, involving the scope, extension and objectives of their clinical development. The endpoints, type and duration of the clinical trials, and which ones need to be completed before and after the marketing authorization, have been debated. The US and European Regulatory Agencies have established new requirements for the clinical development of antidiabetic drugs, with special emphasis on cardiovascular safety. New antidiabetic drugs will need proof of efficacy in terms of glycemic control, in monotherapy and/or in combination therapy, as well as sufficient cardiovascular safety, assessed by an integrated analysis of cardiovascular events performed by an independent Event Adjudication Committee. In some cases, specific safety studies with cardiovascular events as primary endpoints may be necessary. The time needed to complete the clinical development of new antidiabetic drugs may be extended by 2-3 years. (C) 2011 Sociedad Espanola de Diabetes. Published by Elsevier Espana, S.L. All rights reserved.