Lilly/Amylin's Byetta type 2 diabetes agent is "approvable" at FDA as a stand-alone therapy in conjunction with the April 29 approval of exenatide as an adjunct to other oral treatments, the firms said.

Clinical studies submitted in the June 30, 2004 NDA were not designed to evaluate the use of Byetta (exenatide) as a stand-alone therapy.

However, because of the consistent and significant glycemic response demonstrated in the trials, data from two short-term, stand-alone studies were submitted to the agency, Amylin CEO Ginger Graham said during an April 29 investor call.

"We're very pleased they have recognized the potential utility of Byetta and the expansion of its application to patients newly diagnosed with diabetes in the future," the exec stated.

The company declined to release a timeframe for pursuing a monotherapy indication.

Any additional data submitted to FDA to support the monotherapy indication are expected to receive a six-month review, according to Amylin.

Byetta will launch June 1 as an adjunctive therapy to improve glycemic control in patients currently taking metformin, a sulfonylurea or a combination of the products (see ¹ Also see "Lilly/Amylin’s Byetta Type 2 Diabetes Therapy To Launch June 1" - Pink Sheet, 29 April, 2005. ).

The Byetta approval was supported by three 30-week, placebo-controlled trials. A total of 1,494 patients with type 2 diabetes have been treated with exenatide in short- and long-term controlled clinical trials and in long-term open-label clinical trials, according to labeling.

The addition of Byetta to a regimen of metformin, a sulfonylurea or a combination of both resulted in statistically significant reductions in glucose levels at week 30 compared to placebo.

Trial results showed a statistically significant reduction from baseline in mean fasting and postprandial glucose concentrations at 30 weeks compared to placebo as well. The studies appear in the May issue of Diabetes Care.

² Labeling also reports that patients on 10 mcg Byetta experienced a decrease in body weight compared to baseline in each of the three trials.

- Jessica Merrill

Byetta Is “Approvable” As Stand-Alone Therapy

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