Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

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.

"Many patients using basal insulin with or without oral diabetes medications are unable to maintain adequate blood sugar control, particularly at mealtime," said Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. "If approved for this expanded use, BYETTA may provide a complementary addition to basal insulin to improve overall blood sugar control with no weight gain and no increased risk of hypoglycemia. The combination may also offer a mealtime treatment option that is taken only twice a day and does not require dosing titration."

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.

Nausea was the most common adverse event during the 30-week treatment period and decreased over time. Nausea occurred in 41 percent of patients treated with BYETTA compared with 8 percent of patients treated with insulin alone. Hypoglycemia was similar for both groups; major hypoglycemia occurred twice in one patient receiving insulin alone.

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