IBJNews

Lilly, partner find no Bydureon effect on heart rhythm

Back to TopCommentsE-mailPrintBookmark and Share

Eli Lilly and Co., Amylin Pharmaceuticals Inc. and Alkermes Inc. said an analysis of a 148-patient trial found no evidence that their experimental Bydureon diabetes drug causes prolonged heart rhythms.

The analysis, released in summary form Sunday at the American Diabetes Association annual scientific meeting in San Diego, found the drug “did not affect” a heart rhythm called the QT interval, according to the abstract. The analysis includes data the companies previously submitted to the U.S. Food and Drug Administration.

Last October, the FDA refused to approve Bydureon, a weekly version of Indianapolis-based Lilly and San Diego-based Amylin’s diabetes drug Byetta. The agency asked the two companies and Alkermes of Waltham, Mass., to perform a new study looking at whether high levels of Bydureon can cause an abnormal heart rhythm that may increase the risk of sudden cardiac death. The study results will be available in the second half of this year, said Christian Weyer, senior vice president at Amylin.

The results of the current analysis “are very reassuring,” Weyer said. “Ultimately, we need to await the result of the ongoing study.”

The companies plan to resubmit Bydureon for approval “very shortly” after the ongoing study is completed, he said.

European regulators gave approval to Bydureon a week ago.

In other research from the meeting, the companies reported data from a 121-patient study finding that a once-monthly version of Byetta may produce similar blood sugar control to the weekly version of Bydureon over a 20-week period.

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

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. How can any company that has the cash and other assets be allowed to simply foreclose and not pay the debt? Simon, pay the debt and sell the property yourself. Don't just stiff the bank with the loan and require them to find a buyer.

  2. If you only knew....

  3. The proposal is structured in such a way that a private company (who has competitors in the marketplace) has struck a deal to get "financing" through utility ratepayers via IPL. Competitors to BlueIndy are at disadvantage now. The story isn't "how green can we be" but how creative "financing" through captive ratepayers benefits a company whose proposal should sink or float in the competitive marketplace without customer funding. If it was a great idea there would be financing available. IBJ needs to be doing a story on the utility ratemaking piece of this (which is pretty complicated) but instead it suggests that folks are whining about paying for being green.

  4. The facts contained in your post make your position so much more credible than those based on sheer emotion. Thanks for enlightening us.

  5. Please consider a couple of economic realities: First, retail is more consolidated now than it was when malls like this were built. There used to be many department stores. Now, in essence, there is one--Macy's. Right off, you've eliminated the need for multiple anchor stores in malls. And in-line retailers have consolidated or folded or have stopped building new stores because so much of their business is now online. The Limited, for example, Next, malls are closing all over the country, even some of the former gems are now derelict.Times change. And finally, as the income level of any particular area declines, so do the retail offerings. Sad, but true.

ADVERTISEMENT