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Swedish Orphan Biovitrum AB Publ Receives FDA Approval for Kineret for Treatment of NOMID


Tuesday, 8 Jan 2013 02:31am EST 

Swedish Orphan Biovitrum AB Publ announced that the United States Food and Drug Administration (FDA) had approved Kineret (anakinra) for the treatment of children and adults with neonatal-onset multisystem inflammatory disease (NOMID). Kineret is a therapy for NOMID, the most severe form of cryopyrin associated periodic syndromes (CAPS). Kineret was approved for NOMID under an Orphan Drug designation. A priority review was granted by the FDA based on the product's potential to provide a significant advance in therapy for the NOMID patient population where no adequate therapy exists. The Company will provide a prefilled syringe with a graduated label to allow flexible dosing in children. Kineret has been approved for the reduction of signs and symptoms of Rheumatoid Arthritis (RA) in adults since 2001. CAPS is, in its most severe form of NOMID, a life-long and severely debilitating disease. The disease is associated with an overproduction of an immune system protein known as interleukin-1 (IL-1). Untreated patients develop progressive hearing and vision loss, variable degrees of cognitive impairment and joint contractures. Treatment of NOMID patients for five years with Kineret demonstrated that, in addition to controlling the daily symptoms of the disease such as fever, rash, headache and joint pain, important central nervous system (CNS) functions such as hearing and vision remain stable and do not progress on treatment. 

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