10 April 2015 - Horizon Pharma plc, a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated products that address unmet medical needs, today announced the U.S. Food and Drug Administration(FDA) granted Fast Track designation for Actimmune (interferon gamma-1b) in the treatment of Friedreich's ataxia (FA), a degenerative neuro-muscular disorder.

"We commend the FDA for granting Fast Track designation for Actimmune in Friedreich's ataxia to potentially help treat patients suffering from this debilitating disorder, for which there are no FDA approved treatments available," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. "We look forward to continuing our ongoing clinical development program as we evaluate Actimmune in this patient population." 

Medicines may qualify for Fast Track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs. Fast Track designation provides greater access to and more frequent communication with the FDA throughout the entire drug development and review process, with the goal of possibly expediting approval. In addition, Fast Track Designation also provides the opportunity to submit sections of the registration dossier for the target indication on a rolling basis and to be considered for priority review at the time of submission based on forthcoming clinical data.

The Company submitted the Investigational New Drug (IND) application for Actimmune in the treatment of FA in February 2015 and announced plans to begin a Phase 3 study in the second quarter in collaboration with the Friedreich's Ataxia Research Alliance (FARA) and a sub-set of FARA's Collaborative Clinical Research Network (CCRN) study centers in FA.

For more details, go to: http://ir.horizon-pharma.com/releasedetail.cfm?ReleaseID=905891