Celltrion Wins U.S. Phase 3 Trial Approval for Zymfentra in Rheumatoid Arthritis

Celltrion has received approval for a U.S. Phase 3 trial plan for Zymfentra, a treatment for autoimmune diseases.

Celltrion disclosed on the 23rd that the U.S. Food and Drug Administration (FDA) approved the Phase 3 trial plan for CT-P13 SC (Zymfentra). The application was submitted on July 24 (local time).

This global Phase 3 trial will evaluate the efficacy and safety of CT-P13 SC in patients with moderately to severely active rheumatoid arthritis. It is a randomized, placebo-controlled, double-blind, parallel-group study.

The trial will enroll 296 participants, and the treatment period is 52 weeks. The company aims to demonstrate that CT-P13 SC is superior to placebo in clinical response based on ACR50 at week 12.

Zymfentra is the subcutaneous formulation of the infliximab biosimilar Remsima IV. The company completed Phase 3 trials in adults with ulcerative colitis and Crohn's disease and received marketing authorization in the United States, Europe and other regions.

Celltrion said it expects the rheumatoid arthritis Phase 3 trial to help provide treatment opportunities to more patients.

The FDA does not separately notify applicants when it approves applications for new Phase 3 trial plans. The company said it confirmed the approval based on the date 60 days after the application was submitted, in accordance with procedures that set the review period at up to 60 days.