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. I never thought I'd see the day when a Republican Mayor would lead the charge in attempting to raise every tax we have to pay. Now it's income taxes and property taxes that Ballard wants to increase. And to pay for a pre-K program? Many studies have shown that pre-K offer no long-term educational benefits whatsoever. And Ballard is pitching it as a way of fighting crime? Who is he kidding? It's about government provided day care. It's a shame that we elected a Republican who has turned out to be a huge big spending, big taxing, big borrowing liberal Democrat.

  2. Why do we blame the unions? They did not create the 11 different school districts that are the root of the problem.

  3. I was just watching an AOW race from cleveland in 1997...in addition to the 65K for the race, there were more people in boats watching that race from the lake than were IndyCar fans watching the 2014 IndyCar season finale in the Fontana grandstands. Just sayin...That's some resurgence modern IndyCar has going. Almost profitable, nobody in the grandstands and TV ratings dropping 61% at some tracks in the series. Business model..."CRAZY" as said by a NASCAR track general manager. Yup, this thing is purring like a cat! Sponsors...send them your cash, pronto!!! LOL, not a chance.

  4. I'm sure Indiana is paradise for the wealthy and affluent, but what about the rest of us? Over the last 40 years, conservatives and the business elite have run this country (and state)into the ground. The pendulum will swing back as more moderate voters get tired of Reaganomics and regressive social policies. Add to that the wave of minority voters coming up in the next 10 to 15 years and things will get better. unfortunately we have to suffer through 10 more years of gerrymandered districts and dispropionate representation.

  5. Funny thing....rich people telling poor people how bad the other rich people are wanting to cut benefits/school etc and that they should vote for those rich people that just did it. Just saying..............

ADVERTISEMENT