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Health Canada Grants Approval for DOPTELET (avatrombopag) in Two Thrombocytopenia Indications

Thursday, November 09, 2023

Sobi North America, the North American subsidiary of Swedish Orphan Biovitrum AB (Sobi MD), has received approval from Health Canada for DOPTELET MD (avatrombopag), an oral thrombopoietin receptor agonist (TPO-AR). This approval covers the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (IPT) who have not responded adequately to other treatments, as well as the treatment of severe thrombocytopenia in adults with chronic liver disease who are scheduled for an invasive procedure.

Dr. Charles H. Li, MD, FRCPC, a consultant hematologist at the Vancouver General Hospital and clinical associate professor at the University of British Columbia, expressed optimism about the approval. He stated that DOPTELET provides patients with a new oral treatment option without dietary restrictions or the need for constant liver function monitoring. This is particularly significant for individuals with chronic liver disease, offering an alternative to boost platelet counts and optimize hemostasis before invasive procedures, thereby avoiding exposure to blood products and associated expenses.

Chronic immune thrombocytopenia, lasting more than a year in adults, affects approximately 9.5 out of 100,000 individuals in the United States and Western Europe, with a higher prevalence in young adult women.

Sobi Canada, highlighted that DOPTELET's approval provides a practical option for people in Canada at an increased risk of dangerous internal bleeding due to thrombocytopenia. The treatment, taken with food, may be easier to incorporate into daily routines.

Health Canada's approval of DOPTELET was based on data from Phase 3 and Phase 2 studies in chronic IPT patients, as well as two international, multicenter, placebo-controlled Phase 3 studies, ADAPT-1 and ADAPT-2, in patients with chronic liver disease.

DOPTELET demonstrated efficacy in increasing platelet counts in chronic IPT patients, with a favorable safety profile observed in pooled data from 128 patients. The most common treatment-related adverse events in the DOPTELET group were headache, fatigue, bruising, epistaxis, upper respiratory tract infection, arthralgia, gingival bleeding, petechiae, and nasopharyngitis.

In chronic liver disease patients, both ADAPT-1 and ADAPT-2 studies showed that DOPTELET significantly reduced the need for platelet transfusions or rescue procedures for bleeding compared to the placebo group. The treatment also increased the proportion of patients achieving the target platelet count before invasive procedures.

Common treatment-related adverse events in chronic liver disease patients receiving DOPTELET included pyrexia, abdominal pain, nausea, headache, fatigue, and peripheral edema.

Immune thrombocytopenia is an autoimmune disease characterized by low platelet counts, leading to an increased risk of bleeding, while thrombocytopenia is a common complication in chronic liver disease patients.

DOPTELET, an orally active thrombopoietin receptor agonist, stimulates the production of platelets from bone marrow precursors, providing a new therapeutic option for adults with severe thrombocytopenia in chronic liver disease and chronic immune thrombocytopenia who have not responded adequately to other treatments.

 

Source: globenewswire.com

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