Takeda Pharmaceutical Company Limited has announced that the gut-selective biologic Entyvio® (vedolizumab) was approved by China’s National Medical Products Administration (NMPA). The approved indications are for adult patients with moderate to severe active ulcerative colitis (UC) or Crohn’s disease (CD) who have had an inadequate response with, lost response to, or were intolerant to conventional therapies or tumor necrosis factor alpha (TNFα) inhibitors.
Entyvio was included in the first batch list of ‘urgently needed’ overseas medicines for accelerated approval by the NMPA in 2018.
“The Chinese government’s determination to significantly improve access of innovative drugs, and to improve peoples’ quality of life is crystal clear. Including Entyvio in the first list of ‘urgently needed’ overseas drugs, and its accelerated approval process is a clear example of this,” Sean Shan, President of Takeda China, said. “For our part, Takeda is committed to continuing to develop and make available highly innovative medicines and will bring these novel solutions to China’s patients as fast as possible.”