Sobi (Swedish Orphan Biovitrum) has launched Doptelet (avatrombopag) in Europe, which is approved for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD).
Following the official commercial launch in the EU, the UK will be the first country where the thrombopoietin receptor agonist (TPO-RA) is set to launch.
Thrombocytopenia is characterised by a reduction in the number of platelets in the blood and is a common complication in patients with CLD. As liver disease becomes more severe, often the extent of thrombocytopenia also worsens.
Doptelet is designed to mimic the biologic effects of thrombopoietin in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count, according to Sobi.
In two phase III clinical trials, ADAPT-1 and ADAPT-2, Doptelet was shown to effectively increase platelet counts and reduce both platelet transfusions and rescue procedures for bleeding when undergoing invasive procedures in CLD patients with severe thrombocytopenia.
“The launch of Doptelet offers an additional treatment option for patients living with CLD,” said Sofiane Fahmy, head of Europe at Sobi.
“Since the acquisition of Dova Pharmaceuticals, our focus has been on expanding sustainable patient access to Doptelet from the US to Europe. We are delighted that Doptelet is now available in the UK for this initial indication, and we look forward to continue rolling out Doptelet in other European markets,” she added.
Doptelet is also approved by the US Food and Drug Administration (FDA) for the treatment of thrombocytopenia in adult patients with CLD who are scheduled to undergo a procedure.
