Akeso Reports the NMPA’s sNDA Acceptance of Gumokimab for Active Ankylosing Spondylitis
Shots:
- The Chinese NMPA has accepted the sNDA of gumokimab for the treatment of active ankylosing spondylitis (AS)
- sNDA was backed by the P-III (AK111-303) trial in AS, which met all efficacy endpoints, with 1EP (ASAS20 response rate) showing consistent improvements across subgroups, along with 2EP (ASAS40 response rate) & gumokimab delivering rapid symptom relief in activity, physical function, & QoL
- Gumokimab is a humanized anti-IL-17A monoclonal antibody, which is under NMPA review for use in treating mod. to sev. psoriasis following NDA acceptance in Jan 2025
Ref: PRnewswire | Image: Akeso |Press Release
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