Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

Amylin Pharmaceuticals, Inc. (AMLN: Quote) and Eli Lilly and Co. (LLY: Quote) 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.

Register
To receive FREE breaking news email alerts for Eli Lilly And Co. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Stocks saw some volatility following the release of the Federal Reserve's monetary policy announcement on Wednesday but managed to end the day modestly higher. With the upward move, the Dow reached a new record closing high. President Barack Obama sought to emphasize in remarks on Wednesday that the American forces being deployed as part of the fight against the terrorist group ISIS will not have a combat mission. Republican Joni Ernst has moved into the lead in the potentially crucial Iowa Senate race, according to the results of a Quinnipiac University poll released on Wednesday. The poll found that 50 percent of likely Iowa voters would support Ernst if the election were held today, while 44 percent would vote for Democratic Rep. Bruce Braley.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.