Drug-maker Biodel Inc. is one step closer to bringing its fast-acting insulin product VIAject to market, according to a recent article from Dow Jones Newswires.
In December the company submitted its application to the U.S. Food and Drug Administration. Now, the agency has accepted that application for review, meaning the agency will take a close look at the application. It does not accept all applications for review.
The company says VIAject helps reduce the risk of both hyperglycemia and hypoglycemia (low and high blood sugar levels). The insulin is meant to be used in insulin pumps as well as injected during mealtimes.
VIAject has been tested in more than 850 patients in Phase 1, 2 and 3 clinical trials in the U.S., Germany, and India. The company says the application includes information that documents the product’s safety. It includes information about pharmacokinetic, pharmacodynamic and standardized meal studies, as well as two pivotal 6-month Phase 3 clinical trials of VIAject in patients with Type 1 and Type 2 diabetes. It also includes interim results from the long-term, 18-month safety extension trials for patients who completed the Phase 3 clinical trials.
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