Pierre Fabre MÃ©dicament is Granted Authorisation in Australia to Market the Milnacipran JONCIAÂ® to Treat Fibromyalgia
CASTRES, France, November 21, 2011 /PRNewswire/ –
The Therapeutic Goods Administration (TGA), Australia’s regulatory body
for therapeutic products, granted Pierre Fabre Medicament’s milnacipran
market authorisation for the treatment of fibromyalgia (“for the management
Discovered by Pierre Fabre Medicament, 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 Medicament 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(R)
(authorisation granted by the FDA in January 2009).
The TGA’s decision makes Pierre Fabre Medicament 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 Medicament: it highlights the expertise of our research into
conditions affecting the central nervous system, and also confirms our
potential for international development” explains Frederic Duchesne,
Managing Director of Pierre Fabre Medicament, adding that “milnacipran is to
be marketed in Australia in the form of a strategic partnership”.
The TGA’s approval of JONCIA(R) 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(R) 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,
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
With brands including Avene, A-Derma, Ducray, Elgydium, Eludril, Klorane
or Rene 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. Avene 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