#Actimmune interferon gamma copay assistance program registration#
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. 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. 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. "We look forward to continuing our ongoing clinical development program as we evaluate ACTIMMUNE in this patient population." Walbert, chairman, president and chief executive officer, Horizon Pharma plc. "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. 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.
Horizon Pharma plc (NASDAQ: HZNP), 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.
Horizon Pharma plc Receives FDA Fast Track Designation for ACTIMMUNE(R) in the Treatment of Friedreich's Ataxia 23.5 KBĭUBLIN, IRELAND - ( Marketwired) - 04/10/15.
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