China's NMPA Accepts Akeso’s NDA for Ebdarokimab in Moderate-to-Severe Plaque Psoriasis

Ebdarokimab is a novel fully human Interleukin-12/Interleukin-23 monoclonal antibody.

Akeso Inc.’s New Drug Application (NDA) for its fully human IgG1monoclonal antibody ebdarokimab (IL-12/lL-23, AK101) for the treatment of adults with moderate-to-severe plaque psoriasis has been accepted by the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China (NMPA CDE).

Ebdarokimab is a novel fully human Interleukin-12/Interleukin-23 monoclonal antibody.

A total of five clinical trials were conducted with ebdarokimab in patients with moderate-to-severe plaque psoriasis. Two pivotal Phase III clinical trials provided essential efficacy data for ebdarokimab in patients with moderate-to-severe plaque psoriasis at weeks 16 and 52, respectively. The results showed that ebdarokimab had significant efficacy in the treatment of moderate-to-severe plaque psoriasis at both 16 and 52 weeks with a favorable safety profile.

Ebdarokimab was effective in improving patients' quality of life while improving skin lesions.