CHMP adopts positive opinion for Doptelet to treat primary chronic immune thrombocytopenia in adult patients who are refractory to other treatment.- Dova Pharma/SOBI

Swedish Orphan Biovitrum AB (publ) (Sobi) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of Doptelet (avatrombopag) for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). The opinion is now referred to the European Commission for a decision. 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. The European Medicines Agency has already approved Doptelet for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure.