China-based 3SBio Inc. (HKG: 1530) has announced that its multi-center, randomized, double-blind, placebo-controlled study assessing the safety, efficacy, and pharmacokinetics of thrombopoietin in chronic primary immune thrombocytopenia (ITP) in children or adolescents has reached its pre-set primary endpoint. The results of the statistical analysis showed that the study group’s superiority was established compared with the control group, with a statistically significant difference in the overall effective rate (P = 0.0029). No serious adverse events or any suspicious unexpected serious adverse reactions related to the study drug were reported. The company plans to submit a supplementary new drug application for the drug in China in the near future.
Thrombopoietin Profile
3SBio’s recombinant thrombopoietin, marketed under the brand name TPIAO, was first approved for marketing in China in May 2005 as a treatment for chemotherapy-induced thrombocytopenia. A second indication for immune thrombocytopenia (ITP) in adults was approved in 2010. The Phase III clinical study was initiated to assess its use as a pediatric therapy in 10 children’s hospitals and general hospitals in China.
ITP Treatment Landscape
ITP, an acquired autoimmune hemorrhagic disease, requires patients to participate in treatment decision-making to achieve optimal platelet counts while minimizing adverse treatment reactions and reducing bleeding events. China’s ITP treatment guidelines recommend thrombopoietin as a second-line therapy. The successful outcome of this study underscores the potential of 3SBio’s thrombopoietin as a valuable treatment option for pediatric and adolescent patients with chronic ITP.-Fineline Info & Tech
