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FM medication is given negative opinion by European Medical Authority

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Category: Press Releases

Published on Sunday, 26 October 2008 11:15

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FMA UK will work with ENFA to formulate a strategy for Europe as this decision may have implications for two other drugs currently in the licensing process.

Fibromyalgia patients are in despair after the rejection from the European medical agency of the first medicine to treat Fibromyalgia in Europe.

Brussels - The Committee for Medicinal Products for Human Use (CHMP) has submitted a negative recommendation on Cymbalta (common name: Duloxetine hydrochlorideis) today (24.10.2008) to the EMEA, the European regulatory agency for medicines.  Cymbalta is the first medication for the treatment of Fibromyalgia that has been filed in Europe by Eli Lilly for the treatment of Fibromyalgia. The medicine was approved by the US Food and Drug Administration for Fibromyalgia since June 2008.

The reason for the negative recommendation has been disclosed to the public on the EMEA website. However it is suspected that the misperception even among some medical professionals in Europe that fibromyalgia is not a real medical condition must have contributed to the decision. 

Despite the fact that the World Health Organization (WHO) has recognized Fibromyalgia as a disease in 1992, and several well respected medical organizations including the European League Against Rheumatism (EULAR), the American College of Rheumatology and the American Pain Society (APS) have developed criteria and guidelines for the classification and treatment of fibromyalgia, some medical professionals and some governments in Europe have been resistant to recognizing Fibromyalgia as a disease.

“This negative recommendation put the 14 million Fibromyalgia patients in Europe in despair, who have been hoping to have access to the first innovative medicine to treat their disease. I cannot believe that Fibromyalgia patients in Europe are denied access to the medicine that has been helping the patients in the US and other countries in the world.”  Mr. Robert Boelhouwer, President of the European Network for Fibromyalgia Associations (ENFA), expressed his frustration. “ENFA encourages the regulatory agency and its professional committee members to recognize the sufferings that patients are enduring and approve other effective and safe treatment options as soon as possible,” he continued.

Fibromyalgia is a complex disease with chronic widespread pain as the defining symptom and various additional symptoms including fatigue, non-restorative sleep, morning stiffness, irritable bowel and bladder, restless legs, depression, anxiety and cognitive dysfunction often referred to as “fibro fog.”  All of these symptoms cause serious limitations in patients’ ability to perform ordinary daily chores and work and severely affect their quality of life.

Fibromyalgia imposes a large economic burden on society as well as on affected individuals. A study shows that an average patient in Europe consults up to 7 physicians and takes multiple medications over 5-7 years before receiving the correct diagnosis. The debilitating symptoms often result in lost work days, lost income and disability payments. In fact, a Dutch study in 2005 estimated that the average annual cost of fibromyalgia was  €980 million in the Netherlands.  Research in the UK has shown that diagnosis and positive management of Fibromyalgia reduce healthcare cost by avoiding unnecessary investigations and consultations

It is estimated that about 12-14 million people in Europe suffer from fibromyalgia and the epidemic is more prevalent with women (87% of total prevalence). However, due to complex pathology of the disease, a comprehensive diagnosis requires multi-disciplinary approach.  A recent global survey showed that healthcare professionals lack confidence in diagnosing and managing Fibromyalgia. Educating healthcare professionals, patients and the public to promote better understanding and management of Fibromyalgia will benefit patients, healthcare providers and the society.  Some scientists believe that there is an abnormality in how the body responds to pain, and particularly a heightened sensitivity to stimuli.

Currently, two medicines have been approved in the US to treat Fibromyalgia. The US Food and Drug Administration, the equivalent of the EMEA in Europe, has approved the first medicine Lyrica (pregabalin) in June 2007 for specifically treating fibromyalgia and Cymbalta (duloxetine hydrochloride) in June 2008. Both Lyrica and Cymbalta are proven to reduce pain and to improve function in people with Fibromyalgia.

Contact:
European Network of Fibromyalgia Associations (ENFA)
Mr. Robert Boelhouwer
President of ENFA
This email address is being protected from spambots. You need JavaScript enabled to view it.
www.enfa-europe.eu

About ENFA
ENFA is a network of patient association and support groups working in close consultation with the national association in the relevant country. Our joint missions are to conquer the myths and misunderstandings around Fibromyalgia. The network will help collectively push forward the boundaries which currently exist in understanding, experiencing and treatment of Fibromyalgia. Our main goal is to see fibromyalgia receiving the recognition it deserves across Europe as an illness in its own right. FMA UK is a founding member of ENFA.

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