EU approves Kineret (Sobi) for CAPS
Swedish Orphan Biovitrum AB announced that the European Commission (EC) has approved Kineret (anakinra) for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). The decision follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in September 2013. This approval was based on the outcome of a long-term safety and efficacy study in children and adults with the most severe form of CAPS called Neonatal-Onset Multisystem Inflammatory Disease (NOMID), or Chronic Infantile Neurologic Cutaneous and Arthritis syndrome (CINCA). The study was conducted at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health (NIH) in Bethesda, MD, USA.
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