On 8th November 2012, the Federal Drugs Administration (FDA) in the United States received guidance from its Endocrinologic and Metabolic Drugs Advisory Committee on the application for a license for degludec insulin and it’s combination preparation degludec/aspart. Degludec has a protracted delivery following subcutaneous injection allowing for flexibility in the timing of its once daily dosing and low risk of night-time hypoglycaemia. Although the committee had voted in favour of a license, this was only by an 8-to-4 split and there had been a unanimous recommendation (12:0) for a study of the cardiovascular (CV) safety of degludec. This is in marked contrast to the opinion of the European Medicines Agency (EMA), which recommended the granting of a marketing authorisation for degludec on 18th October 2012 with no apparent concerns over CV safety. The Japanese authorities were also satisfied with the CV analyses. So, why should there be this divergence of opinion and who has got it right?
Archives for December 2012
Traditionally, the management of diabetes has centred around pharmacological intervention to treat hyperglycaemia and cardiovascular risk factors, often with minimum input from a health care professional. However, from a patient perspective, daily living consists of multiple choices such as appropriate dietary intake, physical activity as well as drug compliance. Over recent years, the importance of patient education has developed as a means to acquire the skills necessary for active responsibility in the day to day self management of their condition. Indeed, this is recognised in the 2008 NICE guidelines for diabetes as well as the 2011 NICE quality standards.