Valertias has received the European CE Mark for V-GO its disposable insulin delivery device, further expanding its approval portfolio.
The CE, or ‘Conformité Européenne,’ mark is an international symbol for medical devices that adhere to strict quality assurance standards issued by the European Union. Products that have received the CE Mark can be sold in the European Union.
The award means V-GO can be sold in the European Economic Area (EEA), which is made up of the 27 Member States of the EU and Iceland, Norway, Switzerland and Liechtenstein.
The news follows just a few months after V-GO received US Food and Drug Administration (FDA) clearance for the delivery of Novo Nordisk’s product Novolog for the treatment of type 2 diabetes.
This in turn followed approval for use of the device in the delivery of Eli Lilly’s Humalog and meant it could be used in conjuncti9on with the two best selling insulin products.
The importance of having wide-ranging regulatory approval for V-Go was stressed by Valeritas CEO Kristine Peterson.
"The CE Mark, coupled with our FDA 510(k) clearances in December 2010 and February 2011, affords us the opportunity to provide an innovative therapeutic option to the millions of adults who require insulin to treat their diabetes."
More than 55 million adults in Europe have diabetes according to the International diabetes Federation – and in countries where the CE Mark applies there are approximately 37.5 million adults who suffer from diabetes.