FDA Approves Celltrion’s Zymfentra to Treat Ulcerative Colitis and Crohn’s Disease

The U.S. Food and Drug Administration (FDA) has approved Celltrion’s Zymfentra, a subcutaneous injection formulation of its infliximab Remsima, for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) following treatment with an infliximab administered intravenously. Zymfentra (infliximab-dyyb) is the world’s first and only subcutaneous infliximab product. It is approved as a novel drug, and its development is based on Remicade (reference intravenous infliximab).

Approval was based on data from two Phase III pivotal trials that assessed the efficacy of Zymfentra as maintenance therapy in patients with moderate to severe UC (LIBERTY-UC) and CD (LIBERTY-CD). Study results show Zymfentra had a superior response in achieving clinical remission (UC and CD) and endoscopic response (CD) compared to placebo as maintenance therapy after induction therapy of intravenous infliximab over a 54-week period. The overall safety profile of Zymfentra was similar to that of placebo during the maintenance period in both studies, and no new safety signals were identified.

“There remains an unmet need for patients who suffer from the day-to-day burden of living with moderately to severely active Crohn’s disease and ulcerative colitis,” said Thomas Nusbickel, chief commercial officer at Celltrion USA. “The approval of Zymfentra provides an innovative and effective treatment option that offers patients with IBD [irritable bowel disease] an alternative administration option, providing control of how and where they receive their treatment, reinforcing our commitment to providing high-quality and affordable treatment options that deliver substantial value to patients and our healthcare system.”