The Center for Drug Evaluation (CDE) has indicated that Xian Janssen Pharmaceutical’s Tremfya (guselkumab), an IL-23 monoclonal antibody, is set to undergo priority review for the treatment of moderate to severe active Crohn’s disease (CD). The drug, which previously received breakthrough therapy designation (BTD) status, is already approved for use in treating multiple autoimmune diseases.
First granted approval in the U.S. in July 2017, Tremfya made its way to Hong Kong in November 2018, where it was also approved. In December 2019, the drug was approved in China for the treatment of psoriasis, marking it as one of the first clinically urgent overseas drugs to be fast-tracked through the priority review process.- Flcube.com
