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Swedish Orphan Biovitrum AB Publ Files for Kineret Label to Include CAPS


Monday, 19 Nov 2012 06:08am EST 

Swedish Orphan Biovitrum AB Publ announced that it has filed an application for an European Union (EU) Marketing Authorization with the European Medicines Agency (EMA) for Kineret (anakinra) for the indication of cryopyrin associated periodic syndromes (CAPS). The filing is based on positive safety and efficacy outcome data from a long-term treatment study in children and adults with neonatal-onset multisystem inflammatory disease (NOMID), the most severe form of CAPS. The EMA filing follows the filing for Kineret for NOMID with the United States Food and Drug Administration (FDA) in July 2012, which has been granted priority review with an expected approval date of December 25, 2012. 

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