Drug development and licensing in diabetes
Abstract
The drug development process is long and expensive. Regulatory approval is granted following assessment of efficacy and safety, and drugs intended for use in the treatment of type 2 diabetes are also required to demonstrate cardiovascular safety. Once marketing approval has been granted in the UK, an additional step is required prior to a drug's use: cost‐benefit assessment by the Scottish Medicines Consortium and by the National Institute for Health and Care Excellence. Empagliflozin, an SGLT‐2 inhibitor, has recently been granted marketing authorisation and approval for use in the UK. It will be used to illustrate the processes of drug development and licensing. Copyright © 2016 John Wiley & Sons.
Source: Practical Diabetes - Category: Endocrinology Authors: Andrea Llano, Miles Fisher, Gerry McKay Tags: Review Source Type: research
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