Pierre Fabre gains approval for fibromyalgia drug Joncia in Australia; TGA cancels approval for four painkillers

Independent French drugmaker Pierre Fabre says that the Australian regulator the Therapeutic Goods Administration (TGA) has granted market authorization milnacipran for the treatment of fibromyalgia.

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 population, according to the company.

Discovered by Pierre Fabre Medicament, milnacipran (trade name Joncia) 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 and Forest who have been marketing it since 2009 under the name Savella (authorization granted by the FDA in January 2009). Forest’s sales of Savella rose 19.1% to $25.5 million in the third quarter of this year.