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.
Sean Shan, President of Takeda China, said, “Many thanks to the NMPA for officially approving the availability of Entyvio for China’s patients. Its approval brings more treatment options to clinicians, and will enable more IBD patients to return to their normal daily lives.”
“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,” Mr. Shan added. “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.”