Biodel has submitted a new drug application (NDA) to the FDA for clearance to market VIAject as a treatment for diabetes.
VIAject is formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs, according to the company.
Danbury, Conn.-based Biodel said it has been tested in more than 884 patients who participated in phase 1, 2 and 3 clinical trials of the drug in the U.S., Germany and India. Biodel is seeking approval to market VIAject in the U.S. as a 100 IU/cc, pH7 (neutral) injectable liquid, in 10 ml vials and 3 ml pen cartridges.
The NDA includes results from pharmacokinetic, pharmacodynamic and standardized meal studies, two pivotal six-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.