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Biodel seeks US FDA approval for mealtime insulin VIAject to treat diabetes

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Friday, January 1, 2010, 19:33 This news item was posted in Biotech category and has 0 Comments so far.

VIAject, a rapid acting mealtime insulin to treat diabetes, is currently undergoing regulatory review in US, Biodel announced in a press release.

Biodel 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.

VIAject 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.

VIAject is a modified form of recombinant human insulin.Therefore, Biodel is submitting its new drug application for VIAject under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act which governs the review of an NDA for a modified form of a previously approved product.

Section 505(b)(2) of the act allows a pharmaceutical company to submit an NDA based in whole or in part on published literature or on US FDA’s finding of safety and efficacy of one or more previously approved drugs and may result in approval of a drug based on fewer clinical or nonclinical studies than would be required under a full NDA.

No insulin product has been approved under this section of the act, as of now. However, Biodel believed its NDA for VIAject qualifies for review under section 505(b)(2), the release noted.

Biodel has conducted pharmacokinetic, pharmacodynamic and standardized meal studies and 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.

“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,” Biodel’s chairman and chief executive officer, Dr. Sol Steiner, stated.

VIAject’s formulation allows insulin to disassociate, or separate, from the six molecule (hexameric) form to the single molecule (monomeric) form and inhibit re-association to the hexameric form, promoting more rapid delivery of insulin into the blood to produce its desired biological effects.

How insulin helps diabetics

Diabetes is a disease characterized by abnormally high levels of blood glucose and inadequate levels of insulin. Glucose is a simple sugar used by all the cells of the body to produce energy and support life. Humans need a minimum level of glucose in their blood at all times to stay alive.

Insulin is a peptide hormone naturally secreted by the pancreas to regulate the body’s management of glucose. When a healthy individual begins a meal, the pancreas releases a natural spike of insulin called the first-phase insulin release, which is critical to the body’s overall control of glucose.

All patients with Type 1 diabetes must treat themselves with mealtime insulin injections to compensate for the lack of natural pancreatic first-phase insulin release.

As the disease progresses, patients with Type 2 diabetes also require mealtime insulin. However, none of the currently marketed mealtime insulin products adequately mimics the first-phase insulin release.

As a result, patients using insulin typically have inadequate levels of insulin in their systems at the start of a meal and too much insulin in their systems between meals.

This, in turn, results in the lack of adequate glucose control associated with diabetes. The long-term adverse effects of elevated glucose levels include blindness, loss of kidney function, nerve damage and loss of sensation and poor circulation in the periphery, which in some severe cases, may lead to amputations.

Biodel is a specialty biopharmaceutical company focused on the development and commercialization of treatments for endocrine disorders such as diabetes. Biodel’s product candidates are developed using technology which reformulates existing FDA-approved peptide drugs.

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