[Editor's Note: Humalog was approved by the FDA later in 1996, on June 17.]
May 1, 1996
Lilly's Humalog -- First New Insulin in 14 Years -- Wins Approval of European Union Medical Product Licensing Agency
Eli Lilly and Company announced today that it has received approval
from the European Medicine Evaluation Agency in Europe to market
Humalog(TM) for the treatment of diabetes mellitus in
15 European Union member countries. The agency's action
marks the fifth approval to market the drug in any country.
Humalog is the first of a new type of insulin that is designed
to more closely mimic the body's own natural rapid insulin
output after a meal. The agency voted to approve Humalog for marketing
in Europe after reviewing clinical data from multinational studies
that were submitted by Lilly in October 1994. The agency is the
coordinating body for drug registration of all biotechnology products
for European Union member countries.
"The agency's approval of Humalog in Europe is a
significant step forward for Lilly and the state of diabetes care
in European Union member countries," said Richard DiMarchi,
Ph.D., vice president of endocrine research at Lilly Research
Laboratories. "Humalog will give diabetes patients in Europe
an additional resource with which to manage their disease --
one that offers more flexibility and convenience than traditional
People with diabetes live with major inconveniences -- they
have to monitor blood-glucose levels and sometimes inject insulin
several times a day to help their bodies process food. For people
who are using regular human insulin, injections currently should
be timed at least 30 to 45 minutes prior to a meal to allow the
medication to start to work before food is eaten.
A 1995 survey of 453 U.S. insulin-using patients with Type I and
Type II diabetes showed that 43 percent injected insulin right
before a meal and did not wait the recommended 30 to 45 minutes
before eating. This behavior can increase a patient's risk
for hyperglycemia (high blood sugar) or hypoglycemia (low blood
sugar), according to survey author Dr. Richard Bergenstal of International
Diabetes Centers in Minneapolis, Minn.
Humalog may offer people more flexibility. People with diabetes
who participated in clinical trials injected Humalog within 15
minutes before a meal instead of injecting regular human insulin
between 30 and 45 minutes before. Clinical trial evidence showed
that Humalog acted faster than regular human insulin to control
blood glucose-levels after a meal.
"Before Humalog, insulin treatment regimens have improved
glycemic control somewhat but failed to completely reproduce the
action of the body's own insulin," said Bergenstal,
who is participating in Lilly's Humalog clinical trials.
"With Humalog, we are taking a step toward more physiologic
replacement of insulin."
Humalog was discovered and developed by Lilly scientists who found
that the time action of insulin could be accelerated by changing
the order of two amino acids in the human insulin molecule. Humalog
is designed to mimic the body's natural rapid insulin output
in response to eating a meal.
On February 29, 1996, the U.S. FDA Endocrine and Metabolic Drug
Advisory Committee unanimously recommended that the FDA approve
Humalog for marketing in the United States. Currently, Humalog
is pending final action by the FDA for marketing in the United
States; therefore it is not yet available.
Humalog will be launched in Germany in May; launches in other
major European countries are expected to follow rapidly. Lilly
is seeking permission to market Humalog in other countries around
the world, including the Asia-Pacific region, Australia, Canada,
Japan, Latin America, New Zealand and the United States. The company
already has received approval to market the insulin analog in
Russia, South Africa, Switzerland and the Czech Republic, but
to date, the product is only being commercially sold in Switzerland
and South Africa.
Lilly was the first company in the world to receive permission
to market a human insulin analog when Russia's Ministry
of Health approved Humalog. Other company firsts include commercializing
the first insulin product in 1923 and bringing to market the first
human insulin of recombinant DNA origin in 1982.
Lilly is a global research-based pharmaceutical corporation headquartered
in Indianapolis, Ind., that is dedicated to creating and delivering
superior health care solutions -- by combining pharmaceutical
innovation, existing pharmaceutical technology, disease prevention
and management and information technologies -- in order
to provide customers worldwide with optimal clinical and economic
outcomes. Endocrine diseases are one of five therapeutic areas
in which the company is focusing its efforts.
Humalog(TM) (insulin lispro, Lilly)