FDA Cancels Meeting To Review Lilly's Cymbalta
From Associated Press (January 5, 2010)
WASHINGTON--The Food and Drug Administration has canceled a meeting to review Eli Lilly & Co.’s 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 afternoon trading.
Calls placed to Lilly Tuesday were not immediately returned. The company is based in Indianapolis.
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.
Posted: January 2010