EMA approves Kineret to treat Still's disease.- Swedish Orphan Biovitrium.

Swedish Orphan Biovitrum AB (publ) (Sobi) announces that the European Commission (EC) has approved an extension of the indication for Kineret (anakinra) to include the treatment of Still�s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still�s Disease (AOSD), in all 28 European Union (EU) member states.

Still�s disease is a rare systemic multi-organ disorder of auto-inflammatory nature that affects approximately 25,000 children and adults in the EU. In children, Still�s disease (SJIA) is the most severe form of arthritis. It is often associated with fever, rash and joint inflammation.The approval is based on data from clinical trials as well as data from scientific literature and meta-analyses of published data. Overall, the evaluation of the medicine is based on more than 400 patients with Still�s disease. It shows the efficacy of anakinra in both paediatric and adult patients with Still�s disease, with the majority of patients achieving remission as well as an improvement of the signs and symptoms associated with the condition.