Horizon Pharma Says FDA Grants Fast Track Designation For Actimmune

(RTTNews) - Horizon Pharma plc (HZNP) announced the U.S. Food and Drug Administration or FDA granted Fast Track designation for ACTIMMUNE (interferon gamma-1b) in the treatment of Friedreich's ataxia or FA, a degenerative neuro-muscular disorder.

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 or 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 or FARA and a sub-set of FARA's Collaborative Clinical Research Network or CCRN study centers in FA.