The latest US Food and Drug Administration (FDA) 510K clearance covers use of the device, named V-Go, for the delivery of Novo Nordisk’s product Novolog for the treatment of type 2 diabetes.
The decision, which follows similar clearance for use in combination with Eli Lilly’s Humalog granted in December 2010, means the V-Go can be used with, looming patent expiries notwithstanding, the two most widely prescribed insulins in the US.
Last year, according to Lilly, US revenue generated for Humalog was $1.2bn, up 1 per cent on 2009. Novo did not provide 2010 sales figures for Novolog in the US, but did report its insulin franchise holds 43 per cent of the North American market.
Demand for devices
V-Go is a once-daily, disposable, waterproof device that provides a continuous set basal rate and on-demand bolus dosing for meal-time coverage, via a rapid acting insulin analogue.
The patch works by peeling a protective layer from an adhesive backing on the device and applying it to the body such as around the abdomen area.
The technology’s major selling point, according to Valeritas CEO Kristine Peterson, is V-Go’s simplicity and disposability.
"The V-Go Disposable Insulin Delivery Device is the first fully disposable, non-electronic basal-bolus device that is specifically designed with the Type 2 population in mind."
Peterson added that: "We believe that the simple user features of the V-Go will allow more patients with diabetes to adhere to their insulin regimen, which ultimately may lead to better control."
National Institutes of Health (NIH) statistics indicate that, at present, 25.8m US citizens have some form of diabetes, with about 36 per cent being sufferers of type 2.
This means that every day in the US 16m people must administer insulin using one of a number of delivery technologies with syringes and pens and currently dominating the market.