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[IP] Re:Novo & Humalog
In a message dated 12/31/01 10:21:42 AM Central Standard Time,
email @ redacted writes:
This is for Jim, Jeff & Andrew. This was released on 12/26/01. This is NOT
First and Only Insulin Analog Approved for Pump Therapy
New Indication for NovoLog(R) (insulin aspart [rDNA origin] injection)
Offers Additional Treatment Option for Insulin Users
PRINCETON, N.J., Dec. 26 /PRNewswire/ -- Novo Nordisk Pharmaceuticals, Inc.,
today announced the Food and Drug Administration has approved NovoLog(R)
(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
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
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
This is a tremendous accomplishment for pump users to finally get noticed in
the pharmaceutical industry!! Let's go forward and get others interested in
us. We have another year to move other mountains..like the insurance
industry. Anybody read Diabetes Interview this month???
Take care all!! Happy New Year, Formerly Pump Rep, Kathy O
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