China-based EOC Pharma Group has announced that its drug, lusutrombopag, has received marketing approval from the National Medical Products Administration (NMPA) for the treatment of chronic liver disease (CLD) patients with thrombocytopenia. The drug is specifically indicated for patients being prepared for surgery, including diagnostic procedures.
Lusutrombopag: An Oral TPO-RA for Thrombocytopenia
Lusutrombopag is an oral small molecule human thrombopoietin receptor agonist (TPO-RA) that stimulates the production of endogenous platelets. It offers a well-tolerated and more effective treatment option for patients with severe thrombocytopenia who require invasive surgery. EOC obtained exclusive rights to the drug, which was approved in Japan, the US, and Europe in 2015, 2018, and 2019, respectively, from Japan-based Shionogi through a 2019 licensing deal. The drug is marketed globally by Shionogi under the trade name Mulpleta.
Phase III Trial Results and Global Consistency
The NMPA’s approval is based on a Phase III trial in China that demonstrated the drug’s safety and efficacy consistent with previous Phase III studies conducted overseas. The primary efficacy endpoint and key secondary endpoint of the Phase III study in China were in line with the results of two regulatory Phase III studies conducted in Japan and globally. Additionally, there were no new unexpected adverse events (AEs) in terms of safety compared to previous studies, further validating the drug’s profile.-Fineline Info & Tech
