Concord Kirin Moglizumab Injection is planned to be included in the priority review

On July 19, the CDE website announced that Mogamulizumab injection (mogamulizumab) was planned to be included in the priority review

The proposed indication for the drug is adult patients with mycosis fungoides (MF) or Sezari syndrome (SS) who have received at least one systemic treatment in the past

Moglizumab is a CCR4 targeting antibody that has been approved by the FDA for breakthrough therapy and priority review, and has been approved for marketing in the United States

Mogamulizumab (KW-0761) is a humanized CC chemikon receptor 4 (CCR4) monoclonal antibody developed by Kyowa Hakko Kirin

In an open-label, multi-center, randomized phase 3 trial called MAVORIC, a total of 372 patients with mycosis fungoides and Sezari syndrome received mogamulizumab or control drugs

Based on the results of this research, the FDA approved mogamulizumab in August 2018 to treat adult patients with relapsed or refractory mycosis fungoides or Sezari syndrome who have received at least one systemic therapy

Content source: CDE, Pharmaceutical Guanlan