By Fineline Cube China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received orphan drug designation (ODD) status from the US FDA for its hetrombopag olamine as a treatment for primary immune thrombocytopenia (ITP). The drug was approved in China in June 2021 for the treatment of ITP in patients not responding to glucocorticoids and/or immunoglobulins, and obtained Phase III clinical trial approval in the US in January this year for the same indication.
Understanding Primary Immune Thrombocytopenia
Primary immune thrombocytopenia (ITP) is a disorder characterized by increased platelet destruction and impaired platelet production, resulting in decreased platelet counts and an increased risk of bleeding. This condition can significantly impact patients’ quality of life due to the potential for spontaneous bleeding and the limitations it imposes on daily activities.
Market Landscape and Competing Products
In the global market, several similar products are available. GlaxoSmithKline’s Promacta (eltrombopag), Dova Pharma’s Doptelet (avatrombopag), and Shionogi’s Mulpleta (lusutrombopag) are marketed overseas for the treatment of ITP. In China, Novartis’s eltrombopag olamine, used to treat chronic idiopathic ITP in adults, expanded its indication to children aged 6 to 11 in May 2022. Additionally, Fosun Pharma’s licensed avatrombopag is commercially available to treat adult patients with chronic liver disease-related thrombocytopenia undergoing elective diagnostic procedures or surgery.-Fineline Info & Tech