INDIANAPOLIS, SAN DIEGO and WALTHAM, Mass., June 21, 2011
/PRNewswire/ — Eli Lilly and Company (NYSE:
LLY), together with Amylin Pharmaceuticals, Inc. (Nasdaq:
AMLN) and Alkermes, Inc. (Nasdaq:
ALKS), announced today that the European Commission has granted
marketing authorization to BYDUREON™ (exenatide 2 mg powder
and solvent for prolonged release suspension for injection).
BYDUREON, a glucagon-like peptide-1 (GLP-1) receptor agonist, is
the first once-weekly treatment for type 2 diabetes. It delivers
glycemic control in a single weekly dose and is indicated for the
treatment of type 2 diabetes in adult patients in combination with
metformin, a sulfonylurea, a thiazolidinedione, metformin plus a
sulfonylurea or metformin plus a thiazolidinedione.
“As the global impact of diabetes continues to expand, so does
the need for innovative medicines to help people living with
diabetes successfully fit treatment into their lives,” said Enrique
Conterno, president, Lilly Diabetes. “BYDUREON is the first and
only once-weekly treatment for type 2 diabetes and has demonstrated
powerful efficacy in multiple clinical trials.”
The EU Marketing Authorization of BYDUREON is based on review of
the submission package, including data from studies in the DURATION
clinical program in which exenatide resulted in improvements in
glycemic control with just one dose per week. In the data
submitted, BYDUREON showed statistically significant improvements
in glycemic control based on reduction of A1C (a measure of average
blood sugar over three months) between 1.5 and 1.9 percent after
six months. Although BYDUREON was not studied as a weight-loss
product, most patients taking BYDUREON lost weight. Further, the
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