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| |  FDA Approves New Pump Therapy Indication For Novolog (Insulin Aspart) PRINCETON, NJ -- December 27, 2001 -- Novo Nordisk Pharmaceuticals, Inc., announced the Food and Drug Administration has approved NovoLog® (insulin aspart [rDNA origin] injection), the company's rapid-acting insulin analog, for pump therapy in diabetes. NovoLog can now be used in external pump systems suitable for continuous subcutaneous insulin infusion (CSII). NovoLog is the first and only insulin analog indicated for use in insulin pumps. NovoLog has been available since September 2001 in cartridges and vials for the treatment of adults with diabetes mellitus for the control of hyperglycemia. This approval allows NovoLog to be administered continuously through external insulin pumps worn on the body. Martin Soeters, president of Novo Nordisk Pharmaceuticals, Inc., said, "Novo Nordisk's wide range of insulin formulations and innovative delivery systems provides a variety of treatment options to people with diabetes. We are pleased to offer NovoLog as yet another choice for those who use pump therapy to maintain good glycemic control." Bruce Bode, M.D., Medical Director at the Atlanta Diabetes Association, said, "This is very good news for all people with diabetes who use insulin pumps. Now that NovoLog is the only analog approved for pump therapy, these patients can use a rapid-acting insulin analog in their pumps." "Diabetes patients who use multiple daily insulin injections to maintain good glycemic control may benefit from the added flexibility of insulin pumps," Dr. Bode said. "Also, because NovoLog is a rapid-acting insulin analog, pump users have the convenience of dosing just prior to meals." External insulin pumps are comparable in size to pagers, so they can be attached to a belt or placed in a pocket. Insulin pumps allow delivery of insulin into the subcutaneous tissue of the abdomen through special insulin-compatible tubing connected either to a needle or soft cannula (a tiny tube that penetrates the skin). The pump delivers a predefined amount of insulin automatically throughout the day, and additional amounts can be delivered before meals, closely mimicking the function of the normal pancreas. NovoLog is indicated to control hyperglycemia in adult patients with diabetes mellitus. Because it has a more rapid onset and shorter duration of action than regular human insulin, NovoLog should normally be used in regimens together with intermediate or long-acting insulin, and injection of NovoLog should immediately be followed by a meal. NovoLog may also be infused subcutaneously by external insulin pumps. NovoLog is contraindicated during episodes of hypoglycemia and in patients hypersensitive to insulin aspart or one of its excipients. Hypoglycemia is the most common adverse effect of insulin therapy, including NovoLog. Hyperglycemia and ketosis can occur quickly if pumps malfunction and insulin delivery is interrupted. See package insert for more details. NovoLog, made through recombinant DNA technology, is identical to human insulin, except the amino acid asparate is substituted for proline at one point in the molecule. While this modification does not change the insulin activity per unit, NovoLog has a lesser tendency to form molecular aggregates called hexamers than regular human insulin in solution; as a result, upon injection, NovoLog is absorbed more quickly and acts more rapidly and for a shorter duration. NovoLog is the first of several insulin analogs in development from Novo Nordisk. The U.S. Food and Drug Administration approved it on June 7, 2000. Other products in development include premixed and long-acting insulin analogs. NovoLog is available in cartridges for use with the NovoPen® 3 insulin delivery system, Innovo® insulin doser, and the soon to be available InDuo™, the first combined blood glucose monitoring and insulin dosing system. NovoLog is also available in vials for insulin pump therapy in external pump systems suitable for continuous subcutaneous insulin infusion and for syringe delivery. SOURCE Novo Nordisk
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