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 fibromyalgia").
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 population.
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 partnership".
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.