DANBURY, Conn. A maker of treatments for endocrine disorders hopes to receive approval from the Food and Drug Administration for a diabetes drug.
Biodel said Dec. 31 it submitted a new drug application to the FDA requesting clearance to market a formulation of recombinant human insulin as a treatment for diabetes.
Biodel said that VIAject has been tested in more than 880 patients who participated in phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India. The company is asking the FDA to approve marketing of VIAject as an injectable liquid. According to Biodel, VIAject is designed to be absorbed into the blood faster than currently offered rapid-acting insulin analogs.
“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,” said Biodel chairman and CEO Sol Steiner.