October 24, 2008 EMEA recommends against Eli Lilly's, Boehringer Ingelheim's Cymbalta for fibromyalgia by Anna Bratulic The European Medicines Agency's Committee for Medicinal Products for Human Use recommended against extended approval for Eli Lilly's and Boehringer Ingelheim's Cymbalta (duloxetine) as a treatment for fibromyalgia. The committee concluded that the effectiveness of the drug in treating the disease had not been sufficiently shown and that the treatment's benefits did not outweigh its risks. James Russell, global medical director for Cymbalta at Eli Lilly, stated that the drugmakers "remain confident in the duloxetine data." To support their application, the companies submitted data from four placebo-controlled studies involving 1411 patients and one open-label safety study with 350 patients. Currently, there are no medications approved in the EU to treat the disease. Cymbalta has been approved in the EU for the treatment of diabetic peripheral neuropathic pain, major depressive episodes, generalised anxiety disorder and stress urinary incontinence. In June, US regulators granted marketing authorisation for the drug for the management of fibromyalgia.