IBJNews

FDA gets new report on Lilly diabetes drug

Back to TopCommentsE-mailPrintBookmark and Share

Drugmakers Eli Lilly and Co. and Amylin Pharmaceuticals Inc. said Monday that patients taking their potential once-weekly diabetes treatment, Bydureon, saw a significant improvement in cardiovascular risk factors like high blood pressure when compared to patients who received common diabetes treatments.

The companies said a new analysis of late-stage trial data submitted to the Food and Drug Administration showed patients with type 2 diabetes who received Bydureon also saw improvements in body weight and cholesterol levels.

Indianapolis-based Lilly said in a statement that diabetes patients are at least twice as likely as people without the disease to have heart disease or a stroke, and chronic conditions like obesity, high blood pressure or cholesterol increase this risk. The findings will be presented at the 47th European Association for the Study of Diabetes Annual Meeting in Lisbon, Portugal.

Lilly and Amylin, which is headquartered in San Diego, are working with Alkermes Inc. to develop the drug. The FDA plans to make a decision on whether to approve it by the end of January.

It declined to approve Bydureon last October. It asked the companies to run a thorough study that evaluated the effects of high doses of Bydureon on patients' heart rates. It also asked for data from a study that tested the effectiveness and the labeling of the safety and effectiveness, of the commercial formulation of the drug.

Bydureon contains the same ingredient as Lilly and Amylin's diabetes drug Byetta. Alkermes, of Waltham, Mass., created the technology that releases the drug over the course of a week for more convenient dosing. European Union regulators approved Bydureon in June.

Byetta, a twice-daily injection that has been sold since 2005, generated $710.2 million in sales last year.

Lilly shares fell 9 cents, to $36.04 each, in Monday trading.

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. why oh why does this state continue to elect these people....do you wonder how much was graft out of the 3.8 billion?

  2. i too think this is a great idea. I think the vision and need is there as well. But also agree with Wendy that there may be better location in our city to fulfill this vision and help grow the sports of hockey and figure skating in Indy. Also to help further develop other parts of the city that seem often forgotten. Any of the other 6 townships out side of the three northernmost could benefit greatly from a facility and a vision like this. For a vision that sounds philanthropic, the location is appears more about the money. Would really like to see it elsewhere, but still wish the development the best of luck, as we can always use more ice in the city. As for the Ice growth when they return, if schedules can be coordinated with the Fuel, what could be better than to have high level hockey available to go see every weekend of the season? Good luck with the development and the return of the Ice.

  3. How many parking spaces do they have at Ironworks? Will residents have reserved spaces or will they have to troll for a space among the people that are there at Ruth Chris & Sangiovese?

  4. You do not get speeding ticket first time you speed and this is not first time Mr.Page has speed. One act should not define a man and this one act won't. He got off with a slap on the wrist. I agree with judge no person was injured by his actions. The state was robbed of money by paying too much rent for a building and that money could have been used for social services. The Page family maybe "generous" with their money but for most part all of it is dirty money that he obtained for sources that are not on the upright. Page is the kind of lawyer that gives lawyers a bad name. He paid off this judge like he has many other tine and walked away. Does he still have his license. I believe so. Hire him to get you confiscated drug money back. He will. It will cost you.

  5. I remain amazed at the level of expertise of the average Internet Television Executive. Obviously they have all the answers and know the business inside and out.

ADVERTISEMENT