Expert Panel Cancels Meeting
Eli Lilly & Co’s popular antidepressant, Cymbalta, will not get an expert panel review by the Food and Drug Administration to consider the drug as a treatment for pain.
The agency canceled the January 28 meeting of the FDA’s anesthetic and life support drugs advisory committee, reports the Wall Street Journal, “to allow time for the FDA to review new information that is relevant to the benefit risk balance for the proposed new indication.”
Lilly may be granted a future advisory panel meeting in response to its June 2009 application that contained additional information from clinical trials on using the drug to treat lower back pain and osteoarthritis pain. The FDA does not have to follow the recommendation of its expert panels but often does.
This is not the first setback for Lilly concerning Cymbalta. In November 2008, Lilly withdrew an FDA application after the agency questioned how the drug was tested to treat the chronic pain caused by osteoarthritis and lower back pain.
Cymbalta is only approved currently to treat depression, anxiety disorder, diabetic nerve pain and fibromyalgia. It is the second-best seller for Lilly behind Zyprexa, an antipsychotic. Cymbalta earned more than $2.7 billion in sales in 2008, but its patent expires in three years. The patent for Zyprexa expires next year, so the company is looking for new applications can extend the popularity of a drug.
Doctors can still prescribe it off label for other conditions other than that for which it is approved.
Lilly shares were down in afternoon trading.
Lilly’s Record $1.415 Billion Fine
Last January, Lilly had to pay a record $1.415 billion civil penalty for off-label drug marketing, the largest amount paid by a single defendant at that time in the history of the U.S. Department of Justice (DOJ).
Lilly admitted that its sales force targeted doctors at nursing homes and illegally marketed Zyprexa for uses never approved by the FDA, including treating the elderly for sleep disorders, Alzheimer’s disease, aggression, hostility, depression, and dementia.
Zyprexa was never approved for any of those disorders, but is approved for bipolar disorder and schizophrenia.
Lilly reps emphasized that the weight gain side effect would be of benefit to some patients who had trouble maintaining their weight.
IB member attorney Stephen Sheller filed the first complaint in February 2003. The allegations originated from six former Lilly drug marketing representatives who became whistleblowers.
Lilly perpetrated fraud on the public, says Sheller, while the whistleblowers complained within the company about Lilly’s improper marketing practices. All six were eventually fired or forced to resign. #