Lilly's Humalog -- First New Insulin in 14 Years -- Wins Approval of European Union Medical Product Licensing Agency

[Editor's Note: Humalog was approved by the FDA later in 1996, on June 17.]

May 1, 1996
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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 insulin therapies."

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.

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Humalog(TM) (insulin lispro, Lilly)