Sobi has 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, states the company. The 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.
Kineret is now approved for use in children aged 8 months and older who suffer from CAPS. Sobi will provide Kineret for home treatment in a prefilled syringe with a graduated label to allow precise and flexible dosing in children and adults.