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[IP] Humalog approved for pumps in Europe

I found this at a site called  www.docguide.com  There was a news article
date recently about Humamlog in Europe.  Europe has approved humalog for
pumps there.  See below:......

European Union Approves Humalog (Insulin Lispro) For Diabetic Children
And Adolescents

INDIANAPOLIS, IN -- April 17, 2000 -- Lilly's rapid-acting insulin for
the treatment of diabetes, Humalog(R) (insulin lispro), has been cleared
by the European Commission for the treatment of diabetes in children and
adolescents, Lilly announced. Diabetes in children and adolescents is a
serious illness that each year affects thousands of people under the age
of 20 throughout the European Union.

The European Commission also approved the claim that use of Humalog in
subcutaneous pumps -- pumps that inject insulin beneath the skin --
reduces HbA1c better compared with older human insulin medications.
Humalog has been approved for use in subcutaneous infusion pumps since
April 1998 and is the only insulin analog to be approved for this new
indication in the European Union.

"The EU decision is clearly an important step forward in the treatment of
children in Europe who have diabetes," said Smilijana Ristic, M.D.,
senior research physician for Lilly in Europe. "Diabetes in children is a
very serious illness that is not optimally treated. A recent
international study demonstrated that only one-third of children with
diabetes has acceptable blood-sugar control.

The EU decision stating that Humalog delivered in subcutaneous pumps more
effectively reduces HbA1c, or hemoglobin A1c, is another important
milestone for Lilly's rapid acting insulin. HbA1c is an indirect measure
of long-term diabetes control. Improvement in HbA1c has been shown to
reduce the occurrence of diabetes complications.

Specifically, Humalog's new language says, "When used in subcutaneous
infusion pumps, treatment with insulin lispro has been shown to result in
lower glycosylated haemoglobin levels compared to soluble insulin. In a
double-blind crossover study, the reduction of glycosylated haemoglobin
levels after 12 weeks dosing was 0.37 percentage points with insulin
lispro, compared to 0.03 percentage points for soluble insulin

Humalog is the only medication with such labeling in Europe.

"The EU's decision regarding Humalog and subcutaneous pumps clearly is
important for patients who use the newer delivery device systems," Dr.
Ristic said. "Humalog is a safe and effective treatment for diabetes that
has become increasingly popular because of its rapid-acting capabilities.
The European Commission now believes that use of a pump -- already
effective in helping to maintain glycemic control -- is complemented
nicely by treatment with Humalog."

Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of best-in-class pharmaceutical products by applying the latest
research from its own worldwide laboratories and from collaborations with
eminent scientific organizations. Headquartered in Indianapolis, Ind.,
Lilly provides answers -- through medicines and information -- for some
of the world's most urgent medical needs.

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