Horizon gets FDA Fast Track Designation for ACTIMMUNE to treat Friedreich's Ataxia

WASHINGTON - April 13, 2015 - PRLog -- Horizon Pharma plc has announced that ACTIMMUNE® has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA), to treat 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."

The Fast Track designation is usually granted to a treatment intended for life-threatening diseases or conditions and demonstrates the potential to address unmet medical needs. This Fast track designation will provide Horizon with greater access to communicate with the FDA throughout the drug’s research and development phase with the aim of expediting approval for this indication.

Horizon plans to initiate the Phase 3 study for ACTIMMUNE 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. ACTIMMUNE is currently approved by the FDA for use in two rare diseases.  The treatment is already approved to lower the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD), a genetic disorder affecting cell function of the immune system and it’s also indicated to slow the worsening of severe, malignant osteopetrosis (SMO), a genetic disorder that affects normal bone formation.

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