Amylin and Eli Lilly Seek FDA approval for Expanded Use of Byetta in Type 2 Diabetes Patients


Amylin Pharmaceuticals, Inc.and Eli Lilly and Company have submitted a supplemental New Drug Application (sNDA) to the FDA for the expanded use of Byetta (exenatide) injection as an add-on therapy to basal insulin for adults with type 2 diabetes.
Byetta, the first marketed GLP-1 receptor agonist, was approved in the U.S. in April 2005 for the treatment of type 2 diabetes as add-on therapy to diet and exercise for adult patients not achieving adequate glycemic control using commonly prescribed oral diabetes medications. In October 2009, Byetta was approved as monotherapy along with diet and exercise. Byetta is available in more than 60 countries worldwide.

The sNDA is based on a double-blind, placebo-controlled clinical study evaluating Byetta added to Lantus® (insulin glargine). The study showed many hard-to-treat patients with type 2 diabetes who were poorly controlled on basal insulin therapy with or without metformin and/or a TZD achieved A1C control without weight gain or increasing their risk of hypoglycemia. A total of 261 patients receiving insulin glargine, with or without oral agents, were randomized to receive Byetta or placebo in addition to aggressive insulin titration. After 30 weeks of treatment, A1C on average decreased by 1.7 percentage points in patients adding Byetta, compared with a decrease of 1.0 percentage point in patients treated with insulin alone. Both treatment groups showed lower fasting plasma glucose concentrations; however, after morning and evening meals, when Byetta was administered, postprandial glucose control was significantly improved with Byetta compared to placebo. On average, weight decreased by 4 pounds in patients adding BYETTA, compared with an increase of 2 pounds in patients treated with insulin alone. The greater improvement in A1C with Byetta was not accompanied by an increase in hypoglycemia, compared to placebo.

The study was published in the Dec. 7, 2010 Annals of Internal Medicine.


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