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PRINCETON, N.J. (AFX) - Novo Nordisk, a maker of insulin for diabetics, said Tuesday the Food and Drug Administration has approved a category change for its NovoLog drug, developed to treat diabetes in pregnant women.
NovoLog, a rapid-acting form of insulin, now has a Category B rating, indicating adequate studies with pregnant women with Type 1 diabetes have demonstrated that NovoLog does not increase risk to unborn children.
Previously, NovoLog had a Category C rating, indicating that adverse effects on the fetus have been demonstrated in animal reproduction studies and adequate and well-controlled studies in pregnant women have not been conducted to demonstrate safety.
Diabetes and diabetes treatment can be dangerous for pregnant women, so the FDA classifies prescription drugs with specific category ratings.
The category change was based on a trial that compared the safety of NovoLog with human regular insulin in the treatment of 322 pregnant women with Type 1 diabetes. The study found pregnant women using NovoLog had fewer preterm deliveries, reduced risk of neonatal hypoglycemia, had low rates of major hypoglycemia and reduced risks to the fetus.
Novo Nordisk American Depository Receipts fell 69 cents to $82.17 during afternoon trading on the New York Stock Exchange. Copyright 2006 Associated Press. All rights reserved. This material may not be
Copyright 2007 AFX News Limited. All Rights Reserved.
