Navigation Links
European CHMP Adopts Negative Opinion on Cymbalta for the Treatment of Fibromyalgia
Date:10/24/2008

INDIANAPOLIS, Oct. 24 /PRNewswire-FirstCall/ -- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a negative opinion on a Cymbalta(R) (duloxetine hydrochloride) application for the treatment of fibromyalgia.

"Eli Lilly and Company and Boehringer Ingelheim are naturally disappointed by the CHMP's opinion," said James Russell, M.D., global medical director for duloxetine, Eli Lilly and Company. "We remain confident in the duloxetine data."

No medication has been approved in Europe for the treatment of fibromyalgia, a disease characterized by chronic widespread pain.

The 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.(1,2,3,4,5)

The cause of fibromyalgia remains unknown;(6) however, scientists believe it may be related to some combination of genetic disposition(7) and subsequent changes in pain processing in the brain.(6) The disorder, which has a worldwide prevalence ranging from 0.5 percent to 5.0 percent of the population,(8) has a high impact on quality of life. In addition to chronic widespread musculoskeletal pain, many fibromyalgia patients experience other symptoms such as tenderness, fatigue, sleep disturbance, anxiety and depression.(1,9)

In Europe, duloxetine has been approved for the treatment of diabetic peripheral neuropathic pain (DPNP), major depressive episodes, generalised anxiety disorder (GAD) and stress urinary incontinence (SUI). Duloxetine was approved in the United States for the management of fibromyalgia in June 2008 by the U.S. Food and Drug Administration (FDA).

Notes to Editors:

About Fibromyalgia

Fibromyalgia is difficult to diagnose, partly because no diagnostic tests for the disease exist(10) and partly because a number of other co
'/>"/>

SOURCE Eli Lilly and Company
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreichs Ataxia by Santhera
2. ONCOSCIENCE AG, THE EUROPEAN PARTNER OF YM BIOSCIENCES, ANNOUNCES COMPLETION OF PATIENT ENROLLMENT IN PHASE III BRAIN CANCER TRIAL OF NIMOTUZUMAB
3. YM BIOSCIENCES, EUROPEAN PARTNER, ONCOSCIENCE AG, ANNOUNCES INITIATION OF ADVANCED NIMOTUZUMAB TRIALS IN ADULT GLIOMA AND PANCREATIC CANCER
4. Kline Study: Better Brushing Habits Boost European Oral Care Sales
5. Micromet, Inc. to Present at the Sal. Oppenheim 2nd European Healthcare Conference
6. European Centre for Modern Drug Discovery Established in Hamburg
7. SAFC Expands European Commercial Manufacturing and Storage Capacities With $10 Million Investment
8. Cardica Receives European CE Mark for C-Port Flex A System for Use in Coronary Artery Bypass Surgery
9. Biodel Inc. Announces VIAject(TM) Phase II Meal Study Data at the 2007 European Association for the Study of Diabetes Meeting
10. Intellect Neurosciences, Inc. Obtains Validation of European Patent for Alzheimers Vaccine in 19 Countries
11. Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Hodgkins Lymphoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/19/2014)... October 20, 2014 OCTOBER ... Meeting (ABIM). ABIM will take place ... information about ABIM 2014 is now available ... Delegates representing companies and organizations from all ... obtain information on the latest products and ...
(Date:10/19/2014)... The Asian Automatic patient billing report defines and segments ... revenue. The Automatic patient billing market in Asia is ... at a developing CAGR of 7.2% from 2013 to ... Automatic patient billing market, to get an idea of ... of the segmentation of this market in the same ...
(Date:10/19/2014)... The Asian Orthopedic braces and support systems ... analysis and forecast of revenue. The Orthopedic braces and support ... $416.5 million by 2018, at a developing CAGR of 4.4% ... the Asian Orthopedic braces and support systems market, to get ... a glimpse of the segmentation of orthopedic braces and support ...
(Date:10/18/2014)... The “Human Insulin Market- by ... Premixed), Modern Human Insulin (Rapid Acting, Long Acting, ... Tresiba, Others) - Forecast to 2018” provides a ... opportunities, current market trends, and strategies impacting the ... and forecasts of the revenue and share analysis. ...
Breaking Biology Technology:The Asian Automatic patient billing market is estimated to grow to around $463.9 million by 2018 - New Report by MicroMarket Monitor 2The Asian Automatic patient billing market is estimated to grow to around $463.9 million by 2018 - New Report by MicroMarket Monitor 3The Asian Orthopedic braces and support systems market is estimated to grow to around $416.5 million by 2018 - New Report by MicroMarket Monitor 2The Asian Orthopedic braces and support systems market is estimated to grow to around $416.5 million by 2018 - New Report by MicroMarket Monitor 3The Asian Orthopedic braces and support systems market is estimated to grow to around $416.5 million by 2018 - New Report by MicroMarket Monitor 4Medical Human Insulin Market Is Expected to Reach $42 billion by 2019 - New Research Report by MarketsandMarkets 2Medical Human Insulin Market Is Expected to Reach $42 billion by 2019 - New Research Report by MarketsandMarkets 3Medical Human Insulin Market Is Expected to Reach $42 billion by 2019 - New Research Report by MarketsandMarkets 4Medical Human Insulin Market Is Expected to Reach $42 billion by 2019 - New Research Report by MarketsandMarkets 5
... Kevin W. Sharer, chairman and chief executive officer of Amgen ... plan to retire from the Company at the end of ... an orderly transition process, Sharer will step down as CEO ... Company,s Board of Directors until December 31, 2012, at which ...
... OAKS, Calif., Dec. 15, 2011  Amgen (NASDAQ: AMGN ... $0.36 per share dividend for the first quarter of 2012. ... the previous two quarters. The dividend will be paid on ... the close of business on Feb. 15, 2012.  ...
... 15, 2011 Prolong Pharmaceuticals today announced ... spearhead the firms, engineering and facilities planning ...   Having previously directed the construction of the ... Grange Castle facility in Dublin, Ireland, Flachmeyer is ...
Cached Biology Technology:Kevin Sharer, Amgen Chairman and CEO, Announces Plan to Retire With Robert Bradway to Become CEO on May 23, 2012; Sharer Will Continue as Chairman of the Board Until End of 2012 2Kevin Sharer, Amgen Chairman and CEO, Announces Plan to Retire With Robert Bradway to Become CEO on May 23, 2012; Sharer Will Continue as Chairman of the Board Until End of 2012 3Amgen Announces 2012 First Quarter Dividend 2Amgen Announces 2012 First Quarter Dividend 3Prolong's Large Scale Manufacturing of Sickle Cell Product to be Headed by Industry Veteran 2
(Date:10/18/2014)... of patients with undiagnosed, suspected genetic conditions, a certain ... higher molecular diagnostic yield than traditional molecular diagnostic methods, ... The study is being released to coincide with the ... sequencing, which sequences the protein­coding region of the genome ... in a cell or organism), has been rapidly applied ...
(Date:10/16/2014)... war on the human body. Battles are won, ... pancreatic cancer, this stalemate—known as tumor dormancy—can last ... a phenomena that is poorly understood. , ... of Salvatore Torquato, a Professor of Chemistry at ... tumor dormancy and the switch to a malignant ...
(Date:10/16/2014)... infections and worldwide claims the lives of 160,000 ... University have succeeded in developing a promising vaccination ... , Xavier Saelens (VIB/UGent): "We discovered a new ... development of a novel approach to vaccination against ... small children and elderly people." , RSV: ...
Breaking Biology News(10 mins):Study examines type of exome sequencing and molecular diagnostic yield 2Study examines type of exome sequencing and molecular diagnostic yield 3Modeling tumor dormancy 2New perspectives for development of an RSV vaccine 2
... National Oceanic and Atmospheric Administration, and the co-trustees for ... announced today they have started the injury assessment and ... a legal process to determine the type and amount ... to natural resources and their human uses as a ...
... Troy, N.Y. The purification of drug components ... is particularly true of drugs that utilize proteins, which ... impurities. Scientists within the Center for Biotechnology and Interdisciplinary ... magnetic resonance (NMR) to understand and improve an important ...
... The National Institute of Neurological Disorders and Stroke (NINDS), ... two new sites as part of the Morris K. Udall ... grants will provide a five-year investment totaling more than $16 ... for Medical Research in Manhasset, N.Y. NINDS ...
Cached Biology News:Resource restoration planning process begins for BP/Deepwater Horizon oil spill 2Resource restoration planning process begins for BP/Deepwater Horizon oil spill 3Purifying proteins: Rensselaer researchers use NMR to improve drug development 2Purifying proteins: Rensselaer researchers use NMR to improve drug development 3NINDS awards new Udall Centers for Parkinson's Disease Research 2NINDS awards new Udall Centers for Parkinson's Disease Research 3