FDA cancels meeting to review Lilly's Cymbalta

Back to TopCommentsE-mailPrintBookmark and Share

The Food and Drug Administration has canceled a meeting to review Eli Lilly and Co. antidepressant Cymbalta for a new use against chronic pain.

The agency said in a statement Tuesday that the Jan. 28 meeting was canceled "to allow time for the FDA to review new information," about the proposed use.

Lilly shares fell 82 cents, or 2.3 percent, to $35 in early-afternoon trading.

Calls placed to Indianapolis-based Lilly on Tuesday were not immediately returned.

Lilly withdrew an application in November 2008 after FDA reviewers questioned the methodology and dosing in some of the company's trials.

The company submitted a new application last summer that included a study of Cymbalta for chronic pain caused by osteoarthritis, along with new data from a study of lower back pain.

Cymbalta is already approved to treat depression, generalized anxiety disorder, diabetic nerve pain and the pain ailment fibromyalgia.

The drug is Lilly's second-best selling product, behind the anti-psychotic Zyprexa. Cymbalta generated $2.24 billion in sales through the first three quarters of 2009.

Lilly faces the loss of patents protecting several of its top-selling drugs in the next few years. The patent protecting Zyprexa, which generated more than $4 billion in 2008, expires in 2011. Cymbalta's patent expires in 2013.


Post a comment to this story

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

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
Subscribe to IBJ
  1. With Pence running the ship good luck with a new government building on the site. He does everything on the cheap except unnecessary roads line a new beltway( like we need that). Things like state of the art office buildings and light rail will never be seen as an asset to these types. They don't get that these are the things that help a city prosper.

  2. Does the $100,000,000,000 include salaries for members of Congress?

  3. "But that doesn't change how the piece plays to most of the people who will see it." If it stands out so little during the day as you seem to suggest maybe most of the people who actually see it will be those present when it is dark enough to experience its full effects.

  4. That's the mentality of most retail marketers. In this case Leo was asked to build the brand. HHG then had a bad sales quarter and rather than stay the course, now want to go back to the schlock that Zimmerman provides (at a considerable cut in price.) And while HHG salesmen are, by far, the pushiest salesmen I have ever experienced, I believe they are NOT paid on commission. But that doesn't mean they aren't trained to be aggressive.

  5. The reason HHG's sales team hits you from the moment you walk through the door is the same reason car salesmen do the same thing: Commission. HHG's folks are paid by commission they and need to hit sales targets or get cut, while BB does not. The sales figures are aggressive, so turnover rate is high. Electronics are the largest commission earners along with non-needed warranties, service plans etc, known in the industry as 'cheese'. The wholesale base price is listed on the cryptic price tag in the string of numbers near the bar code. Know how to decipher it and you get things at cost, with little to no commission to the sales persons. Whether or not this is fair, is more of a moral question than a financial one.