US FDA Approves Celltrion's Zymfentra for Bowel Disease

Celltrion USA announced that the US Food and Drug Administration (FDA) has approved Zymfentra (infliximab-dyb) for the maintenance treatment of adults with moderate to severe active ulcerative colitis (UC) and Crohn's disease (CD) with intravenous infliximab.

Following the submission of a Biologics License Application (BLA) under the Public Health Service Act 351(a) pathway (the "separate" BLA) in December 2022, the FDA approved Zymfentra based on pivotal Phase III data evaluating the efficacy and safety of Zymfentra. As maintenance therapy in patients with moderately to severely active UC (LIBERTY-UC) and CD (LIBERTY-CD). Based on the results of the LIBERTY UC and LIBERTY CD studies, Zymfentra demonstrated superiority in the primary endpoints of clinical remission (UC and CD) and endoscopic response (CD) compared to placebo as maintenance therapy in patients following induction treatment with the intravenous formulation. infliximab with UC and CD during the 54- week study period .

The overall safety profile of Zymfentra during the maintenance period was similar to that of placebo in both studies, and no new safety signals were observed,as per pharmabiz. "There remains an unmet need for patients who suffer from moderate to severe active Crohn's disease and ulcerative colitis every day," said Thomas Nusbickel, director of sales for Celltrio USA. "The approval of Zymfentra provides an innovative and effective treatment that provides IBD patients with an alternative delivery option that allows treatment to control how and where they receive treatment, reinforcing our commitment to providing high-quality, affordable treatment options that add significant value to patients. And our health system."