Bridgewater, NJ-based Valeritas has cleared another regulatory hurdle. The venture-backed firm said this week it has garnered FDA clearance for its disposable system for subcutaneous delivery of Novo Nordisk's insulin product NovoLog in adult diabetics.
This victory follows the company's receipt of FDA 510(k) clearance in December of the device, called the V-Go, to deliver Eli Lilly's insulin product, Humalog. The device offers an alternative to using syringe and needle injections of fast-acting insulin around mealtimes to control blood sugar levels in diabetics.
The device, which looks to be roughly the shape of a credit card, is designed to be worn over the skin and deliver pre-set bolus doses of insulin over a 24-hour period. A major hurdle in keeping diabetics healthy has been to keep their blood glucose levels under control with insulin and other measures. Yet using needle injections of insulin can be inconvenient and painful, and diabetics often don't take their meds as prescribed to control their disease, making them ill. The V-Go system appears to give patients simplified option for taking insulin.
Valeritas says it's developing multiple drug-delivery systems for diabetics, and V-Go has been tested and found to be safe for use with the fast-acting insulin products NovoLog and Humalog. The firm, which also has a research and production facility in Shrewsbury, MA, has attracted investments from Abingworth, Agate Medical Investments, ATV Capital, CHL Medical Partners, HLM Venture Partners, Kaiser Permanente Ventures, MPM Capital, Onset Ventures, Pitango Venture Capital and US Venture Partners.
- check out the Valeritas release