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Drug development and licensing in diabetes
Author(s) -
Llano Andrea,
Fisher Miles,
McKay Gerry
Publication year - 2016
Publication title -
practical diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.205
H-Index - 24
eISSN - 2047-2900
pISSN - 2047-2897
DOI - 10.1002/pdi.2003
Subject(s) - medicine , empagliflozin , marketing authorization , authorization , drug , drug development , excellence , drug approval , alogliptin , type 2 diabetes , diabetes mellitus , intensive care medicine , pharmacology , bioinformatics , computer security , sitagliptin , computer science , political science , law , biology , endocrinology
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.