Following FDA approval in 2018 and approval from the EMA in 2019, Doptelet® (avatrombopag) has officially been launched in Europe. Designed for the treatment of severe thrombocytopenia in adults with chronic liver disease (CLD), the approval of Doptelet® follows the results of the ADAPT-1 and ADAPT-2 phase III clinical trials, which concluded Doptelet® effectively increases platelet count in CLD patients and reduces the need for both platelet transfusions and rescue procedures in these patients who experience considerable blood loss during surgery.
Thrombocytopenia – a reduction in the number of platelets in the blood – can be a complication of CLD, as the hormone which stimulates platelet production, thrombopoietin, is produced in the liver. As CLD worsens, so does the extent of the patient’s thrombocytopenia. Doptelet mimics the signalling effects of thrombopoietin, stimulating the development and maturation of megakaryocytes, resulting in an increased platelet count.
Produced by Sobi, (Swedish Orphan Biovitrum), the company plans to launch the drug in the UK first, with further expansion into the European market planned thereafter.
“The launch of Doptelet offers an additional treatment option for patients living with CLD,” says Sofiana Fahmy, head of European operations 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.”
Although classified as a low-stable country for CLD prevalence, Belgium has an estimated case rate of 12 per 100,000 in 2014, with an estimated 22,900 cases of Hepatitis C, one of the leading causes of CLD. With Doptelet soon to be available across the European healthcare market, the symptom of thrombocytopenia may soon be alleviated for many patients across Belgium, leading to better clinical outcomes.
References
http://www.pharmatimes.com/news/sobi_launches_thrombocytopenia_med_doptelet_in_eu_1355930
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7045456/
https://pubmed.ncbi.nlm.nih.gov/25090833/
https://www.journal-of-hepatology.eu/action/showPdf?pii=S0168-8278%2818%2932057-9
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