SAN DIEGO and INDIANAPOLIS, Oct.
19, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc.,
(Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today
announced that the U.S. Food and Drug Administration (FDA) has
approved a new use for BYETTA® (exenatide) injection. BYETTA is now
approved as an add-on therapy to insulin glargine, 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 on insulin glargine alone.
"This expanded use for BYETTA is important for clinical care, in
that it provides a new option for the many patients with type 2
diabetes who are not achieving treatment goals," said John Buse, M.D., Ph.D., professor of medicine,
director of the Diabetes Care Center and chief of the Division of
Endocrinology at the University of North
Carolina School of Medicine in Chapel Hill. "BYETTA is
well-suited for use with insulin glargine, offering a simple
fixed-dose regimen that can help improve control of blood sugar
overall and after meals. In a clinical trial, patients using BYETTA
with insulin glargine achieved better glycemic control, without
weight gain or an increased risk of hypoglycemia, compared to
patients using insulin glargine alone."
In the study supporting the expanded use, patients receiving
insulin glargine, with or without metformin and/or a TZD, were
randomized to receive BYETTA or placebo in addition to aggressive
insulin titration. After 30 weeks of treatment, A1C decreased by
1.7 percentage points in patients adding BYETTA, compared with a
decrease of 1.0 percentage point in patients treated with insulin
glargine alone (p