U.S. FDA approves phase 3 trial of Celltrion’s Zymfentra

Zymfentra. [Courtesy of Celltrion Inc.]

South Korea’s Celltrion Inc. announced on Monday that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) phase 3 application for a drug that treats rheumatoid arthritis (RA).

Celltrion’s Zymfentra is the first FDA-approved subcutaneous infliximab, a tumor necrosis factor (TNF)-α inhibitor commonly administered intravenously (IV) for autoimmune diseases.

It is indicated for treatment of patients with inflammatory bowel disease in the United States.

Rheumatoid arthritis is a prevalent autoimmune disease primarily affecting the joints, leading to arthritis and joint functional impairment.

The Phase 3 trial will involve 189 patients with rheumatoid arthritis to assess the efficacy and safety of Zymfentra in two groups: one receiving Zymfentra and the other receiving a placebo.