logo
Share SHARE
FONT-SIZE Plus   Neg

Amylin Pharma, Lilly Say BYETTA Approved For Use With Basal Insulin In Europe

Amylin Pharmaceuticals, Inc. (AMLN) and Eli Lilly and Co. (LLY) said the European Commission has granted marketing authorization to BYETTA as an adjunctive therapy to basal insulin, with or without metformin and/or Actos, for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents. The company noted that patients in the pivotal study achieved better glycemic control overall and after meals.

"The marketing authorization for the use of BYETTA with basal insulin provides a new option for the many patients with type 2 diabetes who are not achieving treatment goals," said Christian Weyer, senior vice president, research and development, Amylin Pharmaceuticals. "In a clinical trial, patients using fixed-dose BYETTA with titrated basal insulin achieved better postprandial and overall glycemic control, without weight gain or an increased risk of hypoglycemia, compared to patients using titrated basal insulin without BYETTA."

The main study included in the EU marketing authorization submission package was a double-blind, 30-week clinical trial published in Annals of Internal Medicine.

Further, as part of the transition plan outside the U.S., Amylin will assume responsibility for exenatide product commercialization efforts on a market-by-market basis by the end of 2013.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
French baby formula maker Lactalis has issued a major international product recall over fears of salmonella contamination. French health authorities have ordered the dairy company to stop selling hundreds of products worldwide, after 26 infants fell ill with salmonella poisoning in France. Salmonella infections can be life-threatening mainly for young children. What's in store for Casey's General Stores Inc. (CASY), KMG Chemicals Inc. (KMG), and Yingli Green Energy Holding Co. Ltd. (YGE) in today's earnings announcement? Payments and commerce solutions provider VeriFone Systems, Inc. is scheduled to report fourth-quarter results on December 12.
comments powered by Disqus
Follow RTT