Doptelet approved in the EU for treatment of ITP

Shares of Swedish Orphan Biovitrum (STO: SOBI), also known as Sobi, gained more than 2% in early trading, as the company revealed that the European Commission 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 (eg, corticosteroids, immunoglobulins) in all European Union member states.

Immune thrombocytopenia (ITP), a rare blood disorder, is an autoimmune disorder characterized 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 approval of Doptelet for the ITP indication is a milestone for people living with ITP across Europe. There is a large unmet medical need within thrombocytopenia and for us this is a great opportunity to be able to give patients access to a new treatment option,” said Ravi Rao, chief medical officer and head of R&D at Sobi.