New drug application for regulatory approval of exenatide for the treatment of type 2 diabetes

Amylin Pharmaceuticals, Inc., and Eli Lilly and Company today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for regulatory approval of exenatide.

Exenatide is the first in a new class of medicines known as incretin mimetics under investigation for the treatment of type 2 diabetes. In clinical trials, exenatide has demonstrated reductions in blood sugar and improvements in markers of beta cell function. Patients in exenatide studies also lost weight.

"The submission of the exenatide NDA is a significant milestone both for Amylin Pharmaceuticals and for our collaboration with Eli Lilly and Company," said Ginger Graham, president and CEO, Amylin Pharmaceuticals. "This NDA includes data on more than 1,800 subjects treated with exenatide. We believe the application provides the FDA with the necessary information to evaluate exenatide for use as a new therapeutic option for people living with type 2 diabetes."

"The rapid increase in the prevalence of diabetes and the need for innovative new treatments has never been more critical than it is today," said John C. Lechleiter, Ph.D., executive vice president of pharmaceutical operations, Eli Lilly and Company. "Many patients with type 2 diabetes are struggling to control their blood sugar and, even with current oral therapies, find that they cannot reach their treatment goals. If approved, we believe exenatide could offer an important and novel treatment option for people with type 2 diabetes."

The exenatide NDA is made up of three major components; chemistry and manufacturing, preclinical and clinical. The clinical component of the submission is based largely on 30-week data from three blinded pivotal trials of exenatide involving more than 1,400 patients who were unable to control their blood sugar on common oral therapies including metformin, sulfonylurea or a combination of both. The submission also includes 52-week open-label data from the extensions of these pivotal studies and from an additional open-label study. In the pivotal studies, exenatide demonstrated statistically significant, sustained reductions in average blood sugar levels as measured by hemoglobin A1c (A1C). Patients in these studies also demonstrated progressive reductions in weight, a secondary endpoint of the studies. The open-label studies demonstrated that the reductions in A1C were sustained through 52 weeks of treatment with average reductions of approximately 1.1 percent. Reductions in weight were also sustained through 52 weeks of treatment with average reductions of approximately eight pounds. In addition, the exenatide data showed improvements in beta cell function, as measured by HOMA-B and proinsulin to insulin ratios, and the restoration of first-phase insulin response, a fundamental response lost early in the development of type 2 diabetes. Exenatide was generally well tolerated across the pivotal trials. The most common adverse event reported was mild to moderate nausea, which occurred primarily at initiation of therapy.

Exenatide is formulated as a sterile, injectable product that, if approved, will be delivered by a pen delivery system.

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