Drug news
Sobi files Kineret at EMA for CAPS treatment
Sobi (Swedish Orphan Biovitrium)) has filed an application for an 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 US Food and Drug Administration (FDA) in July 2012, which has been granted priority review with an expected approval date of 25 December 2012.
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