Biodel Seek Approval for its VIAject from FDA
Biodel Inc. has shared that it has submitted a new drug application to the US Food and Drug Administration seeking approval over its experimental diabetes drug VIAject. The news made its shares jump by 12% to $4.63 in extended trade, after closing at $4.13 Wednesday on Nasdaq.
The company is looking forward to sell VIAject as an injectable liquid in 10-milliliter vials and 3-milliliter pen cartridges in the U. S.
"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 Chairman and Chief Executive Dr. Sol Steiner.
VIAject is categorized as a form of insulin developed to effectively lower blood sugar, by absorbing itself at a faster rate in comparison to the conventional insulin. It has been tested in more than
884 patients in clinical trials in the U. S., Germany and India.
The pharmaceutical company reported that its fiscal fourth-quarter loss had lower to $10.5 million as research and development expenses narrowed to 28%.