Thursday, December 6, 2012

USFDA Grants orphan drug designation to Biodel's Glucagon for Prevention of Hypoglycemia in Congenital Hyperinsulinism Population

Biodel today announced that the FDA has granted orphan drug designation for Biodel’s 'glucagon' for the prevention of hypoglycemia in the congenital hyperinsulinism (CHI) population.

About Congenital HyperInsulinism

CHI is a genetically heterogeneous disorder characterized by excess, dysregulated insulin secretion from pancreatic beta cells. It is the most common cause of persistent hypoglycemia in neonates and infants and it occurs at an incidence of 1:30,000 to 1:50,000 births.
Children who present with this disorder generally require aggressive artificial calorie support in order to prevent hypoglycemia and resulting neurologic damage.

Despite aggressive treatment with available therapies, the estimated prevalence of permanent neurologic damage from breakthrough hypoglycemia ranges from 20% to 50%.

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