To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Humalog Approved by the FDA as First New Insulin in 14 Years URL: http://www.pslgroup.com/dg/979E.htm Doctor's Guide June 17, 1996
INDIANAPOLIS, June 17, 1996 -- The U.S. Food and Drug Administration today granted Eli Lilly and Company permission to market Humalog(R) (insulin lispro (rDNA origin)) for the treatment of diabetes mellitus. The agency's action makes the U.S. the twenty first country in which Humalog has been approved for marketing. Humalog is a new type of insulin that more closely mimics the body's natural rapid insulin output after eating a meal. The agency approved Humalog for marketing in the United States after reviewing clinical data from multinational studies that were submitted to the FDA by href="http://www.pslgroup.com/dg/EliLilly.htm">Lilly in March 1995. "As the first new insulin in more than a decade, Humalog represents a significant step forward for Lilly and the state of diabetes care," said Richard DiMarchi, vice president of endocrine research at Lilly Research Laboratories in Indianapolis. "Humalog will give people with diabetes 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 monitor blood glucose levels daily, take medications or 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 60 minutes before meal to allow the medication to begin working. 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 60 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. Humalog may offer people more flexibility. People with diabetes who participated in clinical trials injected Humalog up to 15 minutes before a meal instead of injecting regular human insulin between 30 and 60 minutes before. Clinical trial evidence showed that Humalog acted faster than regular human insulin to control blood glucose levels after a meal. The most common side effect observed in these clinical trials was hypoglycemia for both regular human insulin and Humalog patients. "Before Humalog, insulin treatment regimens have improved glycemic control but have failed to completely reproduce the action of the body's own insulin," said Bergenstal, a doctor 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. Lilly is seeking permission to market Humalog in other countries around the world, including the Asia-Pacific region, Canada, Japan, Latin America and New Zealand. The company already has received approval to market the insulin analog in 15 European Union member countries, Australia, Russia, South Africa, Switzerland and the Czech Repubilic. The product is being sold in Russia, Switzerland, South Africa, Germany, the United Kingdom and Sweden. Other launches are expected in coming weeks and months in countries where the drug has been approved for sale. On Feb. 29, 1996, the U.S. FDA Endocrine and Metabolic Drug Advisory Committee unanimously recommended that the FDA approve Humalog for marketing. With the FDA's approval, Lilly expects to begin selling Humalog as a prescription product to U.S. customers in August. Lilly was the first company in the world to get permission to market a human insulin analog when Russia's Ministry of Health approved Humalog. Other company firsts include commercializing the first insulin product derived from animal pancreases 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(R) (insulin lispro (rDNA origin), href="http://www.pslgroup.com/dg/EliLilly.htm">Lilly) Complete prescribing information for Humalog is available on request from Kelly Sego at Lilly at (317) 277-6265. Humalog(R) (insulin lispro (rDNA origin)) Facts - First new insulin in 14 years - Discovered in 1989 and developed by Lilly scientists - Two amino acids in the human insulin molecule -- proline and lysine -- were reversed to create Humalog - Amino acid switch causes Humalog to work faster than other insulins - First used as experimental therapy in human clinical trials in 1990 - To date, more than 2,900 people with diabetes in 19 countries around the world have used Humalog in clinical trials - Mimics the body's own rapid insulin secretion after eating a meal - Should be injected up to 15 minutes before a meal - Acts faster than regular human insulin to control blood-glucose levels after a meal - Will be manufactured in Indianapolis, Indiana, and Fegersheim, France - First cleared for marketing in Russia in April 1995 - Also approved for marketing in Australia, South Africa, Switzerland, the Czech Republic and 15 European Union member countries - Commercially available in Russia, Switzerland, South Africa, the United Kingdom, Sweden and Germany - Recommended for U.S. marketing clearance in February 1996 by advisory committee to FDA - Will be sold in U.S. beginning in August in 10ml vials and 1.5 ml cartridges Diabetes Facts Diabetes is a disease in which the body does not produce or properly use insulin, the hormone that "unlocks" the cells of the body, allowing glucose to enter and fuel them. The cause of diabetes is unknown, although both genetics and environment play a role. People with diabetes fall into two categories -- those with Type I (insulin-dependent) diabetes, and those with Type II (non-insulin-dependent) diabetes. People with Type I do not produce any insulin of their own and must take daily insulin injections to stay alive. People with Type II don't make enough or don't properly use their own insulin. Type II is the most common form of the disease. - Nearly 16 million Americans have diabetes - About 700,000 Americans have Type I; 15.3 million have Type II - Diabetes is the fourth leading cause of death in the United States -- more than 178,000 people will die from it or its complications this year - Health care and related costs for diabetes run nearly $100 billion annually - Diabetes is a chronic disease that has no cure - Each year, 12,000 to 24,000 people lose their sight because of diabetes - Ten percent of all people with diabetes develop kidney disease - Each year, 54,000 people lose a foot or leg to diabetes - People with diabetes are two to four times more likely to have heart disease and five times more likely to suffer a stroke - Symptoms of the disease include: frequent urination, unusual thirst; extreme hunger, unusual weight loss, extreme fatigue, irritability, blurred vision, and slow-healing cuts and bruises. Source: American Diabetes Association Fact Sheet, 1996 --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. 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