Biopharmaceutical company Swedish Orphan Biovitrum AB (STO:SOBI) reported on Tuesday the receipt of approval from the European Commission (EC) for the extension of the indication for Doptelet to include the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to corticosteroids, immunoglobulins in all 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. 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 company said Doptelet (avatrombopag) is an orally administered thrombopoietin receptor agonist (TPO-RA) that mimics the biologic effects of TPO in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count.

Doptelet is approved by both the US Food & Drug Administration for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure and by the European Medicines Agency for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure, concluded the company.