October 27, 2008
Lilly Receives CHMP Negative Opinion for Fibromyalgia Drug
Eli Lilly and Company has announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion on a Cymbalta application for the treatment of fibromyalgia.
The Committee for Medicinal Products for Human Use (CHMP) received data on the use of duloxetine in the treatment of fibromyalgia in 1,411 patients in four placebo-controlled studies and 350 patients in one open-label safety study, a total of 1,761 patients in five clinical trials.
James Russell, global medical director for duloxetine at Eli Lilly and Company, said: "Eli Lilly and Company and Boehringer Ingelheim are naturally disappointed by the CHMP's opinion. We remain confident in the duloxetine data."
In Europe, duloxetine has been approved for the treatment of diabetic peripheral neuropathic pain, major depressive episodes, generalized anxiety disorder and stress urinary incontinence. Duloxetine was approved in the US for the management of fibromyalgia in June 2008 by the FDA.