Lilly seeks Cymbalta fibromyalgia claim

Executive Summary

Lilly may be able to offer an alternative fibromyalgia treatment to Pfizer's Lyrica (pregabalin) by June 2008 if its sNDA for Cymbalta (duloxetine) is approved within a standard 10-month review. The filing was announced by the company Aug. 21. Cymbalta is approved for treatment of major depressive disorder, management of diabetic peripheral neuropathic pain and treatment of generalized anxiety disorder in adults (1Pharmaceutical Approvals Monthly March 2007, p. 20). Separately, Lilly released clinical trial data for the serotonin-norepinephrine reuptake inhibitor showing greater reductions in pain severity one week after starting treatment compared to placebo. The sNDA is based on data from 1,400 patients across five clinical trials, the firm said. Pfizer has estimated the fibromyalgia indication could add $1 billion in incremental sales for Lyrica...