February 29, 1996
Lilly's Humalog Recommended for FDA Marketing ClearanceSILVER SPRING, Md. -- Humalog(TM), (insulin lispro) an investigational insulin analog of recombinant DNA origin, was unanimously recommended for marketing clearance today by the Endocrine and Metabolic Drug Advisory Committee of the U.S. Food and Drug Administration. The committee additionally recommended that it be initially released under prescription status. Humalog is the first of a new type of insulin that is designed to mimic the body's own normal rapid insulin response.
The committee's recommendation, while not binding, will be considered by the FDA in its final review of the New Drug Application submitted by Eli Lilly and Company in March 1995.
More than 16 million people in the United States suffer from diabetes, which is the fourth-leading cause of death each year. The toll diabetes takes on people with the disease and their families is enormous -- medical complications lead to kidney disease, blindness and amputations. In the United States alone, the disease costs society some $92 billion each year, according to the American Diabetes Association.
"This is the first truly new insulin recommended for approval in 50 years. We are delighted with the unanimous recommendation for approval," said Richard DiMarchi, Ph.D., vice president of endocrine research at Lilly Research Laboratories in Indianapolis, Ind. "Humalog is designed to help people with diabetes get better control of their disease. As the leader in insulin therapy and diabetes care, Lilly is committed to comprehensive scientific investigation of this insulin."
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, health care professionals recommend that injections be timed at least 30 to 45 minutes prior to a meal to allow the medication to begin working.
A 1995 survey of 453 insulin-using patients with Type 1 and Type 2 diabetes showed that 43 percent injected insulin closer to their meals than recommended. Only 25 percent of the patients surveyed took their insulin more than 30 minutes before they ate. Taking insulin too close to a meal can increase a patient's risk of hyperglycemia (high blood sugar) shortly after the meal and hypoglycemia (low blood sugar) before the next meal, according to survey author Dr. Richard Bergenstal of the International Diabetes Center of Minneapolis.
Humalog may offer people greater flexibility. People with diabetes who participated in clinical trials injected Humalog within 15 minutes of eating 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.
Since their commercialization in the 1920s, insulins have been commercially available in the United States without a prescription because they are lifesaving drugs for people with diabetes.
Bergenstal, a doctor participating in Lilly's Humalog clinical trials, said: "Insulin is a drug that can save lives and reduce complications for millions of people around the world. Humalog's availability without a prescription would be taking the first important step toward more physiologic replacement of insulin. Limiting Humalog's availability will leave many people with yesterday's choices -- insulin treatment regimens that have improved glycemic control somewhat but failed to completely reproduce the time course of action of the body's own insulin."
The advisory committee's recommendation was based on data from worldwide clinical studies that included approximately 3,000 patients who were evaluated over three years.
Lilly presented information about Humalog's effectiveness to the advisory committee based on a number of measures of blood glucose levels. Topics covered in the presentation included Humalog's safety and data on hypoglycemia, immunologic response and mixing Humalog with other insulins. After hearing the presentation, the committee concluded that differences in insulin doses were not clinically significant between Humalog and regular human insulin; and that clinical study designs and endpoints for measuring the drug's effectiveness were adequate to assess its safety and efficacy. The committee recommended that Lilly continue its ongoing studies and plan additional studies in other patient groups that could benefit from Humalog.
Humalog was discovered and developed by Lilly scientists who found that the absorption of insulin injected under the skin could be accelerated by changing the order of two amino acids in the human insulin molecule. Humalog is designed to more closely mimic the body's own natural rapid insulin output in response to eating a meal.
Lilly has launched Humalog in Switzerland and has received permission to market the insulin analog in Russia, South Africa and Lithuania. The company is seeking permission to market Humalog in other countries around the world, including the Asia-Pacific region, Australia, Canada, European Union member countries, Japan, Latin America and New Zealand. The Committee for Proprietary Medicinal Products in Europe also has recommended Humalog for approval to the drug licensing agency for 15 European Union member countries. Lilly expects to launch Humalog in several countries in coming months. At this time, insulin lispro is not approved by the FDA for marketing in the United States.
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 in April 1995. 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(TM) (insulin lispro, Lilly)
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