U.S. FDA approves phase 3 trial of Celltrions Z... > IT/과학기사 | it/science

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.

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