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
Computer and printer maker Hewlett-Packard Co. said Thursday after the markets closed that its second quarter profit fell 21% from last year, hurt by lower revenue and costs related to the planned separation of the company. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations, but its quarterly revenue fell short of analysts' forecast. Accounting software maker Intuit reported a plunge in third-quarter profit, hurt by impairment charges, even as results topped Wall Street estimates, driven by growth in small business segment amid a strong tax season. Struggling teen-apparel retailer Aeropostale Inc. (ARO), Thursday said its first-quarter loss narrowed from a year ago, driven largely by stronger margins even as revenues continued to plunge dropped. Nevertheless, the company lost almost one-fifth of its market value in after-hours trade, with the...
comments powered by Disqus
RELATED NEWS
Trade LLY now with 
Follow RTT