FDA Approves Cymbalta for Treatment of Fibromyalgia

Tuesday, June 17, 2008

Eli Lilly and Co. said Monday it received Food and Drug Administration approval to expand the use of its fastest-growing drug, the antidepressant Cymbalta.

Regulators approved Cymbalta to treat fibromyalgia, a chronic pain disorder. The drug already is approved for diabetic nerve pain, major depressive disorder and generalized anxiety disorder.

Lilly launched Cymbalta in 2004. It was the drugmaker's second-best seller last year, generating $2.1 billion in mostly U.S. sales behind Zyprexa's $4.7 billion. Cymbalta sales rose 37 percent in the first quarter to $605 million.

Cymbalta's 2007 sales represented a 60 percent increase over 2006. That year, the drug notched $1.3 billion in sales, a 94 percent increase over 2005.

Fibromyalgia affects about 5 million Americans. Researchers believe its cause may be related to genetics, stress and changes in brain and spinal cord chemistry and that it leads to increased pain sensitivity.


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