Posted by Michael Wonder on 23 Jul 2019
UCB announces approval of Cimzia in China
22 July 2019 - After receiving priority review in 2018, Cimzia (certolizumab pegol) is now approved in China for the treatment of moderate-to-severe rheumatoid arthritis.
Belgium-based global bio-pharmaceutical company UCB today announced it has received an import drug license from the National Medical Product Administration (NMPA), enabling people living with moderate-to-severe rheumatoid arthritis to access Cimzia (certolizumab pegol) in China. This approval provides the first biologic therapy in UCB’s portfolio in China, allowing the company to transition its agile biopharmaceutical model into this important patient population.
The NMPA granted priority review for the approval of Cimzia to treat moderate-to-severe rheumatoid arthritis in 2018, based on the therapeutic advantage seen with the therapy. The submission was based on Phase 3 clinical trial results, RAPID-C and RAPID-C open-label extension, which demonstrated efficacy and safety for the approved indication in China.
