Biodel, Inc. announced that it has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for clearance to market of VIAject(R) as a treatment for diabetes. VIAjecta(R) is a 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’s chairman and chief executive officer, Dr. Sol Steiner, stated in the press release: “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.”
