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Lilly Withdraws Cymbalta sNDA

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Lilly has withdrawn its sNDA from FDA for Cymbalta for the management of chronic pain. Lilly plans to resubmit the application in 1H09, adding recent positive data from a study in chronic osteoarthritis pain of the knee.
   
Lilly submitted the application in 2Q08 based on three clinical trials: one positive study in chronic osteoarthritis pain of the knee and two studies in chronic low back pain, one positive and one that didn’t meet its primary endpoint. In discussions between Lilly and the FDA, agency reviewers raised questions about efficacy and dosing that revolved primarily around statistical methodology and study design.
   
“This was a difficult decision, but we believe the updated data package will give the FDA a broader basis for reviewing our application,” said John Hayes, M.D., a vice president at Lilly Research Laboratories.
   
The drug is currently FDA-approved for major depressive disorder, generalized anxiety disorder, management of diabetic peripheral neuropathic pain and management of fibromyalgia.

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