Amylin/ lilly plan Byetta monotherapy filing

US drug firms Amylin Pharmaceuticals and Eli Lilly say that data from a study examining the antidiabetic Byetta (exenatide), as a twice-daily monotherapy in treatment naive patients, indicate that it significantly cuts blood sugar levels. The two doses tested, 5mcg and 10mcg, brought about 0.7% and 0.9% reductions in A1C levels, respectively, from an average baseline range of 7.8% to 7.9%.

The 24-week study also showed that around 60% of those treated had A1C levels of less then 7%. In addition, the drug, in common with previously-reported assessments, conferred significant weight loss from baseline.

The firms, which have been co-developing Byetta under a long-standing agreement (Marketletters passim), plan to submit it to the Food and Drug Administration as a monotherapy in early 2008. Currently, it is cleared for the treatment of diabetics who have difficulty controlling blood sugar levels.