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GEN News Highlights : Nov 5, 2010

FDA Clears Fifth Indication for Lilly's Cymbalta as Treatment for Musculoskeletal Pain

Drug achieved over $3 billion in 2009 global sales and accounted for 14% of firm’s revenues.

FDA has approved Eli Lilly’s Cymbalta® (duloxetine HCL) for the management of chronic musculoskeletal pain in adults. Regulatory clearance was based on studies in patients with chronic lower back pain and chronic pain due to osteoarthritis.

The latest approval in the U.S. is the fifth for Cymbalta. The drug was previously cleared for treating major depressive disorder, generalized anxiety disorder, and for the management of diabetic peripheral neuropathic pain and fibromyalgia.

Lilly reported Cymbalta sales of $825.3 million during the third quarter of 2010, up 4% on the same period in 2009. U.S. sales of the drug were down 1%, to $643.2 million, which Lilly says was driven primarily by the impact of wholesaler buying patterns, and partially offset by higher prices. Sales outside the U.S. were up 18%, at $162.8 million, however. This increase related largely to demand resulting from recent launches in Japan and Canada, the firm notes.

Sales of Cymbalta for the full year 2009 were nearly $3.1 billion, up 14% on 2008. Lilly said the drug is only the second in the firm’s history to exceed the $3 billion sales mark. Cymbalta is now second only to Zyprexa in terms of sales revenues, and accounted for 14% of Lilly’s total revenues in 2009.

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