JDRF Statement on FDA Approval of Inhaled Insulin


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Posted by Ellen on 23:24:23 2006/01/30

In Reply to: Re: Konw-Nothings: That's what diabetics hate the most posted by Claudia


JDRF Statement on FDA Approval of Inhaled Insulin

On January 27, 2006, the Food and Drug Administration approved Exubera, an inhalable form of insulin developed by Pfizer, for use in adults. Inhaled insulin may provide a number of benefits for people with diabetes, including the elimination of some injections, more rapid delivery into the bloodstream via the lungs (as opposed to subcutaneous tissue via injections of the pump), and convenience. This could help patients improve blood glucose control, the most important factor in reducing the risk of diabetic complications.

While JDRF supports the development of therapeutics such as this that can improve the lives of people with diabetes, inhaled insulin is not a cure and won't replace the need for people with type 1 diabetes to take daily injections or to continue closely monitoring blood glucose levels. Exubera was designed to be taken mostly at mealtime to provide short-acting insulin, rather than to provide insulin throughout the day. Further, Exubera was not tested in children and has not been approved for use in children. Finally, there are a number of safety concerns raised during the review process that are still being addressed.

While Exubera represents an exciting step forward in insulin delivery, enthusiasm should be tempered with caution as these concerns are addressed. Initially, Exubera may be more appropriate for people with type 2 diabetes, who resist insulin injections and, as a result, do not maintain tight control. In the future, however, inhaled insulin may provide a convenient and less painful alternative to insulin injections for people with type 1 diabetes as well.

Type 1 diabetes is an autoimmune disease in which the body's immune system attacks and destroys the insulin-producing cells of the pancreas. It usually strikes in childhood, adolescence, or young adulthood, but lasts a lifetime. People with type 1 diabetes must take multiple injections of insulin daily or continuous infusion of insulin through a pump just to survive. Insulin, however, does not cure diabetes, nor does it completely prevent its eventual and devastating effects: kidney failure, blindness, nerve damage, amputations, heart attack, and stroke.







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