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Biodel, Inc., announced that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for clearance to market VIAject(R) as a treatment for diabetes.
VIAject(R) 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.
It is Biodel’s most advanced product candidate and has been tested in more than 884 patients who participated in Phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India. Biodel is seeking approval to market VIAject(R) in the United States 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 6-month Phase 3 clinical trials of VIAject(R) 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(R).
Biodel’s chairman and chief executive officer, Dr. Sol Steiner, stated, “We believe our studies demonstrate that patients receiving VIAject(R) 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(R) may offer important clinical benefits to people with diabetes.”
VIAject(R) is Biodel’s proprietary formulation of injectable human insulin for use at mealtime and in insulin pumps. It has been shown to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs.VIAject(R)‘s formulation allows insulin to disassociate, or separate, from the six molecule (hexameric) form to the single molecule (monomeric) form and inhibit re-association to the hexameric form, promoting more rapid delivery of insulin into the blood to produce its desired biological effects.
Source: Biodel, Inc. Press Release