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news.Biodel, a specialty biopharmaceutical company, has reported that it plans to submit a new drug application to the FDA in the second half of 2009 for approval to market VIAject for the treatment of diabetes.
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VIAject is Biodel’s investigational ultra-rapid-acting injectable human insulin intended for meal-time use by people with type 1 and type 2 diabetes.
The new drug application (NDA) will be based upon results from multiple pharmacokinetic and pharmacodynamic studies as well as two completed Phase III studies of VIAject in patients with type 1 and type 2 diabetes.
Sol Steiner, chairman and CEO of Biodel, said: “After investigating the cause of the anomalous data in India and discussing our findings with the FDA, we are now comfortable proceeding with the preparation and submission of the NDA for VIAject in the second half of 2009.”