Celltrion USA announced on March 18, 2024, the availability of ZYMFENTRA (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab. ZYMFENTRA, approved by the FDA in October 2023, is the first FDA-approved SC infliximab for the treatment of moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease, with a recommended dose of 120 mg every two weeks. Approval of ZYMFENTRA was based on phase III pivotal data from the LIBERTY-UC and LIBERTY-CD studies.
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