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news.Irish biopharmaceutical firm Horizon Pharma has granted fast track designation from the US Food and Drug Administration (FDA) for actimmune (interferon gamma-1b) to treat Friedreich's ataxia (FA), a degenerative neuro-muscular disorder.
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In February 2015, the company submitted the investigational new drug (IND) application for Actimmune in the treatment of FA.
The company has also announced plans to initiate a Phase III trial 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.
Horizon Pharma chairman, president and chief executive officer Timothy Walbert said: "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.
"We look forward to continuing our ongoing clinical development program as we evaluate actimmune in this patient population."
Actimmune is a biologically manufactured protein similar to one the body makes naturally to help prevent infection.
Currently, actimmune is approved by the FDA for use in two rare diseases and it is indicated to reduce the frequency and severity of serious infections associated with chronic granulomatous disease (CGD), a genetic disorder that affects the functioning of some cells of the immune system.
Additionally, actimmune is indicated to slow the worsening of severe, malignant osteopetrosis (SMO), a genetic disorder that affects normal bone formation.