Doptelet (avatrombopag) approved in the EU for treatment of primary chronic immune thrombocytopenia,- Swedish Orphan Biovitrium.

Swedish Orphan Biovitrum AB (publ) (Sobi) (STO:SOBI) announces that the European Commission (EC) has approved an extension of the indication for Doptelet (avatrombopag) to include the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) in all European Union (EU) member states. Immune thrombocytopenia (ITP) is an autoimmune disorder characterised by low numbers of platelets, leading to bruising and an increased risk of bleeding. It is estimated that up to 100 per million people live with ITP, and the disorder is considered chronic when symptoms last more than 12 months. Currently, no cure is available, and these patients have usually relapsed after various treatments, yet still require treatment to reduce the risk of clinically significant bleeding.