EC Approves Extension of SOBI’s Doptelet for ITP

Rare Daily Staff

The European Commission approved an extension of Swedish Orphan Biovitrum’s Doptelet to include the treatment of primary chronic immune thrombocytopenia in adult patients who don’t respond to other treatments.

Immune thrombocytopenia (ITP) 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.

Doptelet 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.

It is approved by both the FDA 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 (CLD) who are scheduled to undergo an invasive procedure.

In June 2019, Doptelet was approved by the FDA for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment.

“The European approval of Doptelet for the ITP indication is a milestone for people living with ITP across Europe,” said Ravi Rao, chief medical officer and head of Research & Development at Sobi. “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.”

Photo: Ravi Rao, chief medical officer and head of Research & Development at Sobi