Celltrion's U.S. Phase 3 Trial Plan for Zymfentra in Rheumatoid Arthritis Approved [Regulatory Filing]

[Financial News] Celltrion disclosed on the 23rd that the U.S. Phase 3 clinical trial plan to expand Zymfentra's indication to rheumatoid arthritis had been approved.
The trial will evaluate the efficacy and safety of Zymfentra in patients with moderate to severe active rheumatoid arthritis. It will involve 296 participants and last 52 weeks.
At Week 12, Celltrion plans to compare the proportion of patients whose symptoms improved by at least 50% according to American College of Rheumatology assessment criteria, in order to demonstrate whether Zymfentra is superior to placebo. The trial will be randomized, placebo-controlled and double-blind.
Celltrion submitted the clinical trial application to the U.S. Food and Drug Administration (FDA) on July 24. The FDA does not separately notify companies when it approves plans for new Phase 3 clinical trials. Celltrion determined that the trial plan had been approved after the maximum 60-day review period under FDA regulations had elapsed.
Zymfentra is a subcutaneous formulation developed from Remsima IV, an infliximab biosimilar. It is currently approved in the United States, Europe and other markets for the treatment of adult ulcerative colitis and Crohn's disease. Celltrion plans to expand its indication to rheumatoid arthritis through this trial.   

[email protected] Bae Han-geul Reporter