Horizon Pharma's Actimmune Fast Track'd for neuro-muscular disorder

• The FDA designates Horizon Pharma's (NASDAQ:HZNP) Actimmune (interferon gamma-1b) for Fast Track review for the treatment of Friedreich's ataxia, a rare genetic neuro-muscular disorder that affects one in 50,000 people in the U.S. It is caused by gene mutations that limit the production of frataxin, a protein that plays a key role in cells' mitochondria. There are currently no treatments for the disease.
• Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
• Actimmune is currently approved to slow the worsening of severe, malignant osteopetrosis, a genetic disorder that affects normal bone formation. It is characterized by abnormally dense bones that are prone to fracture.