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
Burger King has introduced a donut burger in Israel to celebrate the Jewish festival of Hanukkah. The burger will be called the SufganiKing, a play on the Hebrew word for donut, which is sufganiyot. The burger will be sold for about $4. Ciena Corp., a provider of communications networking solutions, on Thursday reported a turnaround to profit in the fourth quarter on higher revenues and lower expenses. However results for the quarter missed analysts' estimates. Looking ahead, the company forecast revenue for the first quarter of fiscal 2017 in line with analysts' expectations. Wearable fitness device maker Fitbit Inc. said it has acquired the assets of struggling smartwatch startup Pebble, including key personnel and intellectual property related to software and firmware development. The acquisition excludes Pebble's hardware products. Financial terms of the deal were not disclosed.
comments powered by Disqus
Follow RTT