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FDA grants Biodel orphan drug designation for rare insulin disease

Friday, December 7, 2012

The FDA has given special designation to glucagon, developed by specialty pharmaceutical company Biodel,for patients with congenital hyperinsulinism (CHI), or abnormally low blood sugar—a rare disorder that affects children.

CHI occurs in 1-in-30,000 to 50,000 births, and children who have it generally need aggressive artificial calorie support to prevent hypoglycemia and neurologic damage, but neurologic damage still occurs in about 20% to 50% of cases.

The FDA grants orphan drug designation to treatments for rare diseases. Companies who receive the designation are eligible for incentives like FDA grant-funding for clinical trial costs, tax credits, waiver of user fees and a seven-year period of marketing exclusivity following regulatory approval, compared with the five that new drugs normally receive.

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