Biodel has submitted a new drug application (NDA) to the FDA for clearance to market VIAject as a treatment for diabetes. VIAject is Biodel’s proprietary formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs.
The company said that VIAject has been tested in more than 884 patients who participated in phase 1, 2 and 3 clinical trials of the drug in the US, Germany and India. Biodel is seeking approval to market VIAject in the US as a 100 IU/cc, pH7 (neutral) injectable liquid, in 10ml vials and 3ml pen cartridges.
Reportedly, the NDA includes results from pharmacokinetic, pharmacodynamic and standardised meal studies, two pivotal 6-month phase 3 clinical trials of VIAject in patients with type 1 and type 2 diabetes, as well as interim results from the long-term, 18-month safety extension trials for patients who completed the pivotal phase 3 clinical trials. The data from these studies consistently document the safety and efficacy of VIAject.
Sol Steiner, chairman and CEO of Biodel, said: “We believe our studies demonstrate that patients receiving VIAject had faster reductions in blood glucose activity, reduced risks of hyperglycemia and hypoglycemia and less weight gain than patients who received recombinant human insulin, and that VIAject may offer important clinical benefits to people with diabetes. I congratulate our team on submitting the NDA and reaching this important milestone in the development of our lead product candidate.”