Pharmaceutical giant Eli Lilly & Co.'s (LLY) efforts to get its antidepressant drug Cymbalta approved for the additional indication of chronic pain, appears to have hit a snag as the FDA's Anesthetic and Life Support Drugs Advisory Committee meeting scheduled for January 28 to evaluate the proposed indication, has been cancelled.
In a statement issued Tuesday, the regulatory agency said that the meeting has been canceled "to allow FDA time to review new information," about the proposed indication.
Lilly submitted the supplemental New Drug Application seeking approval of Cymbalta for chronic pain in the second quarter of 2008 based primarily on outcomes of three clinical trials - one positive study in chronic osteoarthritis pain of the knee and two other studies - one positive and one that is supportive but didn't meet its primary endpoint in chronic low back pain, accorsding to Lilly.
In November 2008, Lilly withdrew its application for the additional indication of Cymbalta for chronic pain after the FDA reviewers raised questions about efficacy and dosing that revolved primarily around statistical methodology and study design.
Last June, the company resubmitted its supplemental New Drug Application for Cymbalta for the management of chronic pain including new data.
Cymbalta is already approved by the FDA for four indications - for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia" -- all in adults at least 18 years old. Cymbalta is not approved for use in pediatric patients.
The drug carries a black box warning regarding the "increased risk of suicidal thinking and behavior in "children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders."
Cymbalta is Lilly's second-best selling drug. In 2008, the drug raked in total sales of $2.69 billion, an increase of 28% over 2007. The sales of Cymbalta continue to be driven by recent approvals for depression in new markets, complemented by growth from other indications in existing markets. For the nine months ended September 30, 2009, the drug logged in sales of $2.24 billion, up 14% over the comparable period a year before.
According to the National Institutes of Health, 100 million people in the United States suffer from chronic pain, costing about $79 billion a year in health care and lost work time. The approval of Cymbalta for the proposed fifth indication. - chronic pain in the U.S, if it happens, opens up a vast new market for Lilly. Cymbalta was recently approved by both Mexico and Brazil for chronic pain.
The FDA approval pathway of painkillers is among the most challenging since it has a lot of checks to mitigate risks and ensure safe use.
LLY, which has been trading in the range of $27.21-$39.76, in the last twelve months, closed Tuesday's trading at $35.19, down 1.76%, on a volume of 7.5 million shares.
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