Biodel Submits VIAject® new Drug Application to FDA for Treatment of Diabetes
News Dec 31, 2009
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® as a treatment for diabetes.
VIAject® 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® 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® 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®.
Biodel’s chairman and chief executive officer, Dr. Sol Steiner, stated: “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. I congratulate our team on submitting the NDA and reaching this important milestone in the development of our lead product candidate.”
University of Huddersfield Honorary Award Goes to RSC’s First Woman PresidentNews
The first woman President of the Royal Society of Chemistry, Professor Lesley Yellowlees, will collect an honorary award from University of Huddersfield, which will be presented at the University’s November Award Ceremonies.READ MORE
Drug Discovery Alliance Formed to Help Increase Drug Development Success RateNews
Two prominent preclinical safety companies have launched a unique European alliance to address the high safety-related failure rate in drug development.READ MORE
First Ever Online Event Focused on Cannabis ScienceNews
Analytical Cannabis is pleased to announce that the final line-up of speakers for the first ever cannabis science online event, The Science of Cannabis 2017 has been confirmed.READ MORE