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UPDATE 1-Europe agency rejects Lilly drug for fibromyalgia

Fri Oct 24, 2008 9:06am EDT

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NEW YORK, Oct 24 (Reuters) - The European Medicines Agency has recommended against approval of Eli Lilly and Co's (LLY.N) Cymbalta for treating the pain and fatigue condition fibromyalgia.

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Recommendations by the agency's Committee for Medicinal Products for Human Use are generally adopted by the European Commission within a couple of months.

Fibromyalgia is a mysterious ailment characterized by chronic widespread pain that afflicts mostly women. No medication has been approved in Europe for the treatment of fibromyalgia, according to Lilly.

Cymbalta, which is approved in Europe for treating depression, anxiety and other conditions, was cleared by U.S. regulators in June for fibromyalgia. Pfizer Inc's (PFE.N) Lyrica is also approved for fibromyalgia in the United States.

Cymbalta, which is known generically as duloxetine, is one of Lilly's most important products. The Indianapolis-based drug maker reported on Thursday that Cymbalta sales jumped 40 percent in the third quarter to $716.4 million. (Reporting by Lewis Krauskopf; Editing by Steve Orlofsky)



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