AMLN, LLY, ALKS
IMO, too many lay people and investors do not appreciate the reduction in HbA1C levels of 1.5%-1.9% after 6 months of treatment with Bydureon on a 1/week injection schedule. That sounds like a very small %, and hence no big deal. But a T2 diabetic with an HbA1C
of 8.5% has an opportunity to reduce that to 6.6-7%, meeting ADA guidelines. Normal HbA1C for non-diabetics is considered to lie in range of 4.5-5.5%.
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EU Beats FDA, Approves Weekly Diabetes Drug Bydureon
6/21/2011
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 BYDUREON submission builds upon six years of market experience with BYETTA® (exenatide) injection, the twice-daily form of exenatide that is available in more than 70 countries worldwide. The most common side effect with BYDUREON in clinical trials was mild-to-moderate nausea, which affected approximately 20 percent of patients and decreased over time in most patients. Other common side effects were vomiting, diarrhea and constipation.
In the U.S., the New Drug Application for BYDUREON (exenatide extended-release for injectable suspension) was submitted to the U.S. Food and Drug Administration (FDA) in 2009. The FDA issued a complete response letter and requested further data in late 2010. The companies plan to submit a response in the second half of 2011. BYDUREON is the proposed trade name.
BYDUREON is delivered using a biodegradable microsphere technology developed by Alkermes. The medicine offers a continuous release of exenatide with just one weekly dose. <<<
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