CASTRES, France, Nov. 21, 2011 /CNW/ - The Therapeutic Goods
Administration (TGA), Australia's regulatory body for therapeutic
products, granted Pierre Fabre Médicament's milnacipran market
authorisation for the treatment of fibromyalgia ("for the management of
Discovered by Pierre Fabre Médicament, milnacipran has been developed
for this purpose in collaboration with Cypress Bioscience (taken over
by Royalty Pharma) and Forest Laboratories. Milnacipran is a mixed
serotonin-norepinephrine reuptake inhibitor.
Pierre Fabre Médicament granted the rights for North America for the
treatment of fibromyalgia to Cypress Bioscience (Royalty Pharma) and
Forest Laboratories who have been marketing it since 2009 under the
name Savella® (authorisation granted by the FDA in January 2009).
The TGA's decision makes Pierre Fabre Médicament the first
pharmaceutical laboratory to offer a medicine in Australia to treat
fibromyalgia, a disease suffered by between 2 and 4% of the local
Following on from the authorisation granted in the United States, this
approval from Australia confirms the potential for the international
development of milnacipran.
"The approval of milnacipran by the TGA is doubly encouraging for Pierre
Fabre Médicament: it highlights the expertise of our research into
conditions affecting the central nervous system, and also confirms our
potential for international development" explains Frédéric Duchesne, Managing Director of Pierre Fabre
Médicament, adding that "milnacipran is to be marketed in Australia in the form of a strategic
The TGA's approval of JONCIA® is based on an application outlining three pivotal phase III clinical
studies, each one lasting three months and conducted in the United
States and Europe. In these studies, involving more than 3,000 patients
affected by fibromyalgia, the milnacipran, administered in doses of 100
mg and 200 mg milnacipran, demonstrated a clinically significant
reduction in pain as well as the alleviation of symptoms during
self-evaluation (by the patient him/herself). The clinical development
of milnacipran in fibromyalgia is based on the assessment of a number
of 'responsive' patients, that is to say patients that demonstrated a
clinically significant and simultaneous improvement with regards to
these two assessment criteria. Furthermore these studies highlighted a
significant improvement in terms of fatigue and sleep.
Long-term phase III studies have confirmed that the effects of
milnacipran are maintained beyond the first six months of treatment.
Furthermore, milnacipran was generally well tolerated, most of the
undesirable effects being weak to moderate in terms of severity. The
balance between the benefits and risks of JONCIA® has been judged to be positive by the TGA.
Fibromyalgia affects between 2% and 3% of the population, most of whom
are women (80%). Identified by the WHO in 1992, it presents itself as a
syndrome combining debilitating pain, chronic fatigue and sleep
problems. Many experts, including rheumatologists, pain specialists and
psychiatrists, are continuing to work on the condition to try and
pinpoint its causes, mechanisms and treatment. A multidimensional and
multidisciplinary approach to the disease is currently recommended,
combining treatment with drugs, physical rehabilitation, therapeutic
patient education and if necessary, psychotherapeutic treatment.
About the Pierre Fabre group:
The Pierre Fabre Laboratories, the second largest independent
pharmaceutical group in France, achieved a turnover of 1.86 billion
Euros in 2010, with international sales accounting for more than 50%.
Their activities cover all aspects of healthcare, from ethical
medicines and over-the-counter drugs (OTC) to derma-cosmetics.
The Pierre Fabre Laboratories have some 10,000 employees, 1,300 of whom
are dedicated to R&D. In 2010, the company allocated 22% of its drug
sales to R&D, focusing on three main areas : oncology, the central
nervous system and dermatology.
With brands including Avène, A-Derma, Ducray, Elgydium, Eludril, Klorane
or René Furterer, the Pierre Fabre Laboratories are France's market
leader when it comes to cosmetics, hair care, oral products and
dermatological products sold in pharmacies. Avène is the leading
dermo-cosmetics brand sold in France, and one of the biggest in Europe.
To find out more, go to http://www.pierre-fabre.com
SOURCE Laboratoires Pierre Fabre
For further information:
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